bluuebunny/crossref_metadata_2025 huggingface dataset:
#1605 Development of an app for a science-based prescription of haemodialysis
Authors: Peyronel Francesco , Rossi Alberto , Palazzini Giulia , Tagliavini Dante , Baccini Federica
Published: May 2024

Background and Aims

The delivery of an adequate haemodialysis (HD) dose (i.e., a target single-pool Kt/V (spKt/V) of 1.4 per session) is often challenging, especially in patients with huge urea distribution volumes (V). On the other hand, patients with an extremely small V, such as children, are at higher risk of disequilibrium syndrome, which is caused by an excessive or overly rapid correction of urea levels, particularly during the first HD session. The treatment prescription often neglects many elements contributing to the final delivered HD dose, whereas a systematic and comprehensive evaluation of all adjustable parameters could improve the management of patients, not only facilitating the achievement of treatment goals, but also avoiding short- and long-term complications. We aimed at developing a web app capable of predicting the delivered HD dose, given a wide range of parameters, and using renowned kinetic equations relevant to urea clearance in HD.

Method

The platform used to develop our app is based on Angular, an open-source framework to develop web applications. Specifically, it can be used to realise single-page apps and it is only for frontend. This fits our case, since a backend is not required due to the absence of huge databases or complex operations. The application is grounded on a stepper component, a paradigm to guide the user step-by-step during the data entry process. It consists of three phases, namely (1) patient, (2) haemodialyser, (3) target spKt/V. The last section is also for output. A modification of any input triggers a real-time output change.

Results

We developed a free access user-friendly web app, through which HD professionals can simulate a treatment prescription and obtain an estimate of the delivered dose in terms of spKt/V. The app is structured in three sections and all calculations are based on validated formulas and kinetic equations applicable to HD:

The output “expected spKt/V” changes in real time, after any modification of the input parameters. The result can thus be compared to the treatment goal (i.e., 1.4 for a standard HD session; 0.55 for a first treatment, aiming at reducing the risk of disequilibrium syndrome), as suggested by international guidelines and expert opinions.

Conclusion

We developed a user-friendly web app, which will be freely accessible online by HD professionals, aimed at predicting the delivered HD dose (spKt/V) considering a wide range of patient- and prescription-related parameters. The application of such a tool in everyday clinical practice, particularly in cases requiring a more accurate definition of the actual delivered dose, could improve the management of patients through a personalisation of the treatment. This could enhance prescription adjustments aimed at achieving an adequate spKt/V in patients receiving an insufficient HD dose; on the other hand, it could help preventing disequilibrium syndrome in patients with very small urea distribution volumes.
#2499 Multicenter observational study on the impact of continuous monitoring of vascular access on the survival and quality of life of patients on dialysis
Authors: Russo Domenico , Satta Ersilia , Romano Carmine , Erbaggio Gioacchino , Santoro Gianluca , Scarpati Luisa , Maio Monica D I , Iacono Fabrizio Lo
Published: May 2024

Background and Aims

AVE is a multicenter observational study aimed at evaluating the improvements in dialysis efficiency, AVF longevity and mortality that can be achieved by implementing both monitoring by a multidisciplinary team. The universal goal of AV monitoring is to identify early events such as stenosis and intervene before thrombosis, thus maximizing the longevity of access and minimizing morbidity.

Method

This study takes advantage of the opportunity to use data from 19 hemodialysis centers and approximately 1000 patients and to correlate and examine variables that are commonly reported with each treatment, trends in AV use, trends in patient characteristics, and the practice associated with VA. The data were collected by nurses in a specific section of the management database at each treatment for 5 years.

Results

Trends at the beginning and at the end of the study were evaluated, and Kaplan Maier curves were performed regarding the survival of the VA and the survival of the patients. The average age of 1000 patients enrolled was 73.5 years. Native AVF was used by 79%, AVG by 2% and CVC by 19%. With increasing age, the use of CVC goes from 6% (15-39 years) to 50.5% in patients over 85 years old. The most frequent complications were: Thrombosis 16.5%, Infections 5.5%. VA-related hospitalization days are 28.7% of total days. The average dialysis goals achieved were: QB 290 ml/Min; purified blood 69.7 L; KT/V:1.35. The AVE study, the survival curves evaluated in aggregate were not different between men and women during the observation period (year 2018: p = 0.327; year 2019: p = 0.174; year 2020: p = 0.343).

This finding was also confirmed when the survival data were analyzed according to gender and chronological age. No difference was observed between genders while the significant difference (p = 0.000) between chronological age levels was confirmed as shown in the Figure

Conclusion

By interpreting data collection for specific performance measures using accurate reports, healthcare professionals can highlight AV performance/inefficiencies and provide correct information to clinical staff to support them in their daily clinical practice and decision making.
#2838 Dialysis regret is associated with level of information about health status but not with frailty
Authors: Schulte-Kemna Lena Sophia , Jazah Mohamed Nooreddin , Künzig Miriam , Bettac Lucas , Kächele Martin , Schroeppel Bernd
Published: May 2024

Background and Aims

Elderly patients (>75 years of age) are the fastest growing group on dialysis with a high burden of multi-morbidity, functional dependence and frailty. Treatment decisions about End-Stage Renal Disease (ESRD) in this group are complex and quality of life, development of functional status and independence are often given higher priority than prolongation of life. Studies from the U.S., Canada and the Netherlands have shown varying degrees of dialysis regret (7–61%) [1–3]. As frailty is common among patients on dialysis and associated with poor clinical outcomes, the aim of this study was to determine the prevalence of regret in having started dialysis and associated risk factors.

Method

This cross-sectional, multicenter, prospective study in southern Germany included 123 adult patients on maintenance dialysis. Dialysis regret was assessed by a single question as part of a 6-item questionnaire. Frailty status was assessed based on modified Fried criteria and by self-assessment using a 5-point visual analogue scale (VAS). Statistical analysis was performed using Fisher's exact test and Chi-square test.

Results

The median age was 68 years, 71% were male, 40% of the participants were considered frail using the Fried criteria. Only 7/123 (5.7%) patients reported regretting the decision to have started dialysis (Table 1). 85% of patients reported sufficient information about their own health status. We found a significant correlation between the level of information regarding own health status and dialysis regret. There was no correlation of dialysis regret with age, sex, frailty or dialysis vintage. Even though frailty status was not correlated with dialysis regret, frail patients were significantly less informed about their own health status. Of note, 82% of patients reported that the decision to initiate dialysis was driven mainly by the health care team or their family (Fig. 1). The main reasons for starting dialysis were prolongation of life and the feeling of having no other choice (Fig. 2).

Conclusion

Dialysis regret was uncommon in our cohort of elderly dialysis patients and was associated with the level of information about health status but not with age, sex, frailty status, comorbid conditions or dialysis vintage. This underscores the importance of patient-education and the process of shared-decision making.
#2225 Educational level and gender are associated with emotional well-being in a cohort of Dutch dialysis patients
Authors: Bakker Wisanne , Theunissen Maurice , Ozturk Elife , Litjens Elisabeth , Courtens Annemarie , van den Beuken Marieke , Hemmelder Marc
Published: May 2024

Background and Aims

Patients undergoing dialysis have an impaired health-related quality of life (HRQOL). There are conflicting data from small series whether patient-related factors such as educational level have an impact on experienced HRQOL. The aim of this study was to investigate the association between educational level and HRQOL in dialysis patients.

Method

In a single-center retrospective cross-sectional study HRQOL was measured using the Kidney Disease Quality of Life Short Form-36 (KDQOL-SF36) in prevalent chronic dialysis patients. Educational level was categorized into low, intermediate and high subgroups. Univariate and multivariate regression analyses were performed to assess the effects of age, gender, ethnicity, and dialysis vintage on the association between HRQOL and educational level.

Results

129 chronic dialysis patients were included. The median age of the patients was 65.0 years and 58% of the patients were male. The median age did not differ between men and women (67.0 vs. 63.0 years, p = 0.673). Median dialysis vintage was 15.0 months. Patients with an intermediate educational level (OR: 4.37 [1.89-10.13]) and a high educational level (OR 4.13 [1.04-16.42]) had significantly higher odds of higher emotional well-being than patients with a low educational level. The odds for women compared to men were 2.83 [1.32-6.06] for better general health and 2.59 [1.15-5.84] for emotional well-being. There was no interaction between gender and educational level for both subdomains. Each year of increasing age was associated with decreased physical functioning (OR 0.94 [0.91–0.97]).

Conclusion

Low educational level and male sex were associated with worse emotional well-being compared to intermediate and high educational level and female sex in dialysis patients. Physical functioning decreased with increasing age.
#2628 A haemodialysis patient-centred model of care with a multidisciplinary programme: what is its clinical and health efficiency impact?
Authors: Martínez-Vaquera Shaira , Sorribes MaPaz , Martínez-Sánchez Teresa , de León Ignacio Ponce , Martínez-Pérez Oscar , Díaz-Cuervo Helena , Cuervo Jesús , Macário Fernando
Published: May 2024

Background and Aims

Chronic kidney disease (CKD) constitutes a public health concern due to its notable morbidity & mortality and associated costs. The Patient Care Coordination program (PCC) provides comprehensive and personalized care to haemodialysis (HD) patients. This study evaluated the cost-effectiveness of PCC compared to standard of care (SoC).

Method

The study included patients in 9 HD clinics (5 PCC, 4 SoC) in Catalonia, Spain, in 2020-2021. A comparative effectiveness evaluation was conducted to compare change in Individual Patient Performance Score (IPPS, score 0-100, evaluates parameters such as vascular access, adequacy of HD, anaemia, mineral bone disease, arterial hypertension, nutrition/hydration status) and number of hospitalisations of PCC patients vs SoC during the first year in the program. Instrumental variables (IV) regression analysis was performed to address potential confounding; number of interactions with program specialists was a valid IV to estimate degree of PCC use. An incremental cost-effectiveness analysis (iCEA) through microsimulation was performed using the effectiveness data from the previous step, population data from the renal patient registry of Catalonia, and the cost of hospitalisations obtained from the Public Health System.

Results

127 patients in PCC and 363 patients in SoC were included. The degree of PCC use had a positive impact on IPPS variation during the first year of the program (p = 0.012). In the iCEA the PCC program resulted in a mean gain of 3.4 additional IPPS points, a reduction of 0.2 hospitalisations per patient, and reduced mean costs of €1,265 per patient in the first year compared to SoC, resulting to be a dominant alternative (Fig. 1).

Conclusion

The holistic and interdisciplinary approach to the patient has further highlighted the relevance of programme use and not only belonging to the programme in achieving clinical goals. The PCC program represents thus a dominant alternative, with greater effectiveness and total cost savings that could sum up to €5.5 million per year in the region due to reduced hospitalizations. This approach may be an alternative to address the challenges of CKD and optimise the allocation of healthcare resources.
#2057 Sex differences in bioimpedance-spectroscopy-derived fluid status and body composition of maintenance hemodialysis patients
Authors: Mussnig Sebastian , Niknam Janosch , Gülmez Dilara , Krenn Simon , Hecking Manfred
Published: May 2024

Background and Aims

Bioimpedance-spectroscopy-(BIS)-derived estimates of fluid status and body composition are associated with mortality in patients undergoing maintenance hemodialysis (HD). Previously, thresholds for improved survival were identified for volume overload (VO, <2.5 L), VO relative to extracellular water (VO/ECW, <15%), lean tissue index (LTI, 15-20 kg/m2) and fat tissue index (4-15 kg/m2). However, these thresholds did not distinguish between sexes. Considering current efforts to untangle differences between male and female kidney disease patients, we aimed to analyze BIS data stratified by sex.

Method

We retrospectively evaluated pre-HD BIS measurements using the whole-body “Body Composition Monitor” device (Fresenius Medical Care). Measurements were conducted at the “Vienna Dialysis-Center”, a large tertiary dialysis center in Vienna, Austria. Continuous variables were described as medians and interquartile ranges and compared between sexes using Wilcoxon tests. Differences in proportions of males and females within the above-mentioned target ranges of body composition parameters were tested using Chi-Square tests and Fisher's exact tests.

Results

In November 2022, the Vienna Dialysis-Center cared for 304 patients, 159 of whom underwent BIS measurements. A total of 137 patients remained for analysis after excluding erroneous results (62% male, 38% female). The median [interquartile range] age among analyzed male and female patients was 60.0 years [48.0; 72.0] and 65.5 years [57.8; 75.3], and the median dialysis vintage was 28.9 months [12.1; 52.7] and 27.2 months [14.8; 61.9], respectively. VO (2.7 vs 1.9 L, p = 0.025), LTI (13.4 vs. 11 kg/m2, p < 0.001) and FTI (11.1 vs. 14.2 kg/m2, p = 0.036) differed significantly between males and females but VO/ECW did not (14.3 vs. 12%, p = 0.4). 27.1% of males (n = 23) were within 15-20 kg/m2 LTI compared to 7.7% of females (n = 4, p = 0.007). Differences in the proportions of male and female patients within optimal ranges of VO (43.5% vs. 61.5%, p = 0.062) and FTI (67.9% vs. 50.0%, p = 0.058) were close to reaching statistical significance.

Conclusion

We discovered relevant differences in fluid status and body composition among patients undergoing maintenance HD not only in absolute numbers, but also in the proportion of patients within the optimal range of LTI. Considering sex differences in body composition but (on average) equal mortality among HD patients, optimum target ranges of BIS measurements may differ between sexes. Our findings from this relatively small cohort call for large-scale sex-specific analyses of fluid status, body composition and outcomes in maintenance HD patients.
#329 Effectiveness of dosing strategies of polymyxin B among sepsis patients with and without renal replacement therapies
Authors: Rajan Asha K , Thunga Girish , Shanbhag Vishal , Chaudhuri Souvik , Kunhikatta Vijayanarayana , Rajan Surulivel , Attur Ravindra Prabhu
Published: May 2024

Background and Aims

Despite numerous population pharmacokinetic studies on polymyxin B, a gap exists in establishing uniform dosing strategies among sepsis patients due to various clinical and patient related factors. The International Consensus guidelines, provide detailed dosing calculation for colistin but not for polymyxin B in renal impairment patients [1]. We aimed to compare and evaluate the effect of various dosing strategies of both polymyxin B and colistin among sepsis patients with and without renal replacement therapies (RRT) in the clinical setting.

Method

We conducted a retrospective audit on adult patients (aged≥ 18 years) diagnosed with gram negative sepsis, both with and without RRT, who were administered polymyxins. Data was collected from the medical records of patients admitted to critical care setting of a tertiary care hospital from January 2018 to December 2022. Patients who received polymyxin B doses for less than 3 days, pediatric, neonate patients or those discharged against medical advice were excluded. Data such as demographic details, RRT, polymyxin type and dosage, and therapy outcomes were collected. Polymyxin B dosing strategies were converted into low dose group (LD) [≤100 mg >150 mg loading dose (ld) and <150 mg maintenance dose (md)], usual dose group (UD) [150 mg ld and 150 mg md] and high dose (HD) [150 mg ld and >150 mg md] to evaluate its effectiveness [2]. Linear and logistic regression were used for continuous and categorical outcomes respectively. All statistical analyses were performed using IBM SPSS vs 29.0 [3].

Results

Our study cohort included 550 patients with mean age of 59.79 ± 15.78 years, and majority of them being male patients (55.2%). A total of 243 (39.6%) patients were on RRT. Among the study population, 465 (84.5%) patients were on polymyxin and 146 (26.5%) were on colistin therapy. Regression analysis of different regimens of Polymyxin B prescribed with various doses showed UD group (p = 0.04) as well as HD group (p = 0.05) with better outcome in terms of improvement. Among the Polymyxin B cohort patients on RRT, HD group showed better outcome (p = 0.045). There was a significant mean difference between polymyxin B dosing strategies with respect to ventilator-free days (p = 0.006), while the other clinical outcomes showed non-significant results.

Conclusion

Our results suggest polymyxin B dosing strategy with a loading and maintenance dose of 150 mg in general patients. In patients with RRT, a loading dose of 150 mg and maintenance dose of >150 mg is warranted. Further population pharmacokinetic studies with large sample size of RRT patients on polymyxin B is required.
#782 Latent profiles of patients undergoing maintenance hemodialysis based on hemodynamic indicators
Authors: Baroz Frederic , Suri Rita , Sharma Abhinav , Tom Alexander , Beaubien-Souligny William , Brophy James , Takano Tomoko , Mavrakanas Thomas
Published: May 2024

Background and Aims

Both intradialytic hypotension and intradialytic hypertension are conditions occurring frequently during hemodialysis and are associated with unfavorable clinical outcomes. However, they remain incompletely understood and poorly defined in the literature. Since intradialytic parameters are now captured automatically in electronic medical records in many institutions, machine learning could emerge as an innovative tool for hemodialysis clinical research. Latent Profile Analysis is a model-based clustering method. It allows to identify hidden subpopulations derived from a set of observed indicator variables, maximizing between-group differences and within-group similarities.

Method

The objectives of this study were to identify latent profiles using a set of hand-crafted indicators and to interpret these subgroups of patients in a clinically meaningful manner. We conducted a retrospective single-center cohort study of adult patients receiving hemodialysis between January 2017 and December 2022 in Montreal. Given the highly heterogeneous nature of this population, we only enrolled incidental patients. The data were extracted from the NephroCare database, which is the clinical information system used by dialysis teams in our center. Sixteen indicators were derived from time series of blood pressure and heart rate measurements, capturing various patient-centric aspects of intradialytic hemodynamics, including trends, zeniths, nadirs, and time-related features. Latent Profile Analysis involved fitting a series of models, and the best model was selected based on fit indices, evaluation metrics, and clinical interpretation of the distribution of indicator within identified profiles. The primary analysis used complete-case data, and a sensitivity analysis assessed the impact of missing data through multiple imputation. Internal model validation was conducted using k-fold cross-validation.

Results

The selected model consisted of four profiles with varying variance and null covariance across indicators. Fig. 1 presents radar plots summarizing the identified profiles. Profile 1 included patients with prolonged early nadirs and a nadir-to-zenith transition pattern at the session level. Profile 2 was characterized by frequent nadirs and zeniths without a specific timing preference. Profile 3 comprised patients with infrequent blood pressure variations altogether. Profile 4 included patients with frequent early nadirs but no zeniths. The model demonstrated good generalization to unseen cases and exhibited relative robustness to missing data.

Conclusion

In this preliminary study, we demonstrated that Latent Profile Analysis can identify clinically meaningful subpopulations of hemodialysis patients based on hemodynamic indicators. The association between the identified profiles and hard clinical endpoints remains to be established.
#2470 Isolated diastolic hypertension in hemodialysis patients
Authors: Torino Claudia , Mallamaci Francesca , Sarafidis Pantelis , Ekart Robert , Balafa Olga , Del Giudice Antonio , Aucella Filippo , Morosetti Massimo , Tripepi Rocco , Marino Carmela , Tripepi Giovanni Luigi , Zoccali Carmine
Published: May 2024

Background and Aims

Isolated diastolic hypertension (IDH) is relatively rare in the general population (prevalence about 6.5%, Front Cardiovasc Med. 2021;8:810105) and of uncertain etiologic implications. The prevalence of this alteration in the hemodialysis (HD) population and the etiologic implications of IDH have not been studied.

Method

We investigated the prevalence and the risk for all-cause death and cardiovascular events of isolated diastolic hypertension in a population of 534 HD patients enrolled in 7 centres in 3 European countries (the EURECA-m working group). BP was measured by a golden standard method in this population (48 h ABPM) using well-validated instruments (AAMI/ESH/ISO). Along with recommendations by the European Society of Hypertension guidelines, recordings were made at 15-minute intervals during the day and 30 minutes at night. According to a consensus document by the EURECAm working group (Nephrol Dial Transplant. 2019;34:1542-1548), isolated diastolic hypertension was defined as 48 h diastolic BP > 80 mmHg with a systolic BP <130.

Results

Among 534 HD patients, thirty-one (5.8%) had isolated diastolic HTN, which is very close to the prevalence estimated in the general population (6.5%). During a mean follow-up of 2.6 years, 138 patients died, 188 had at least one CV event, and 249 experienced the combined event. In univariate analyses, diastolic hypertension was associated with death (HR 0.21; 95% CI: 0.05-0.86, P = 0.03) and the combined outcome of death and CV events (HR 0.42, 95% CI: 0.20-0.88, P = 0.02). However, these associations were no longer significant after adjustment for age and sex (all P > 0.45). Additional sensitivity analyses substantially confirmed these findings. No effect modification by age or gender was observed in these associations.

Conclusion

In a large cohort of HD patients studied by state-of-the-art 48-hour BP monitoring, the prevalence of isolated diastolic hypertension in HD patients (5.8%) is close to that registered in the general population (6.5%). This alteration predicts the risk for clinical outcomes in unadjusted analyses but not after adjustment for age and sex. Isolated diastolic hypertension is as rare as it is in the general population and unlikely to contribute to the high risk of adverse clinical outcomes in the dialysis population.
#608 Effects of shared decision-making on the prognosis of peritoneal dialysis patients
Authors: Shin Ho Sik , Kil Song Yi , Park Byung Hwa , Kim Ye Na , Jung Yeonsoon , Rim Hark
Published: May 2024

Background and Aims

Patients with chronic kidney disease (CKD) require shared decision-making (SDM) processes when choosing a dialysis method. Peritoneal dialysis (PD) guarantees patient autonomy; thus, SDM is even more important. Based on these findings, we aim to highlight the benefits of PD and increase the rate in which patients choose PD. In order to increase the rate of PD implementation, patients must actively participate in dialysis decisions, and SDM process is necessary between doctors and patients. So, we investigated the effect of SDM on the prognosis of patients with CKD. We focused on the effects of SDM on patient death, survival rates, hemodialysis conversion, emergency room visits, hospitalization days, and outpatient visits. The results of this study suggest that SDM has a positive impact on increasing the number of patients who choose PD and reduce unnecessary medical cost.

Method

Among patients with chronic kidney failure from eight hospitals in Korea who started dialysis, 256 who participated in a pilot project for home management of PD were included in the present study. A mixed-methods study was conducted using questionnaires and semi-structured interviews. Our study focused on the effects of SDM on patient death, survival rate, hemodialysis conversion, emergency room visits, hospitalization days, and outpatient visits.

Results

A significant difference was observed in the number of days of hospitalization per admission (p = 0.0044) between the SDM and non-SDM groups. However, no significant differences were observed in survival rate, rate of conversion to hemodialysis (HD), survival rate after conversion to HD, emergency room visit rate, number of hospitalizations per patient, outpatient visit rate, medical cost, hospitalization cost, outpatient cost, and phosphate-binding agent prescription rate.

Conclusion

The number of hospitalization days per admission decreased throughout the SDM process. Continued communication between patients and medical staff on how to manage PD in the long term after making the decision to undergo dialysis will be beneficial in promoting the home management of PD patients.
#2967 C-reactive protein/serum chloride ratio: a novel marker of all-cause mortality in prevalent chronic haemodialysis patients
Authors: Amado Ernesto Francisco Valga , Monzon Tania , Santana Angelo , Santana Ana Yurena Sánchez , Anton-Perez Gloria , Vega Nicanor , Ruiz-Santana Sergio , Rodriguez-Perez Jose Carlos , Perez Patricia
Published: May 2024

Background and Aims

Serum chloride (Cl-) is an emerging marker of mortality in hypertension, sepsis, heart failure and chronic kidney disease. The pathophysiological mechanism is unclear, but haemodynamic and inflammatory factors have been suggested. As C-reactive protein (CRP) is an established marker of inflammation and prognosis in haemodialysis patients, we sought to determine whether there is an association between the CRP/Cl- ratio and prognosis in these patients.

Method

Retrospective cohort study. We included n = 281 prevalent patients in our chronic haemodialysis programme between 19 January 2022 and 11 August 2022. The mean follow-up was 10 months. The sample was divided into quartiles according to CPR/Cl— ratio values. Baseline demographic, analytical and bioimpedance data were collected (Table 1). Survival time was recorded in all patients and analysed using the Kaplan-Meier method.

Results

The median CPR/Cl— ratio was 0.04 mg/mEq (0.02; 0.12). Women accounted for 31.8%. 28.9% had underlying diabetic nephropathy. Overall survival at 10 months was 87.9%. Patients who died had a higher CPR/Cl— value [0.12 (0.04; 0.19)] vs [0.04 (0.02; 0.10)] (p = 0.0005). In addition, those in the fourth quartile had a lower probability of survival compared to the other quartiles (p = 0.0011, log-rank test) (Fig. 1).

Conclusion

Higher values of the CPR/Cl index were associated with higher all-cause mortality in our sample of prevalent haemodialysis patients.
#653 Changes in iron markers and D-dimer levels during enarodustat treatment depends on different iron prescription patterns in hemodialysis patients
Authors: Hamano Takayuki , Teruya Keita , Maruyama Aya , Mitobe B S Yuko
Published: May 2024

Background and Aims

Iron preparations are commonly administered with erythropoiesis-stimulating agents or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PH inhibitors) in hemodialysis patients to promote hematopoiesis and prevent iron deficiency. A recent study highlighted the causal relationship between thrombosis and upregulated serum transferrin levels due to iron deficiency. Additionally, rapid increase of hemoglobin (Hb) during HIF-PH inhibitor use is also considered a risk factor for the development of thromboembolism. Therefore, monitoring iron parameters and Hb is essential for managing anemia and thrombosis risk. We investigated the impact of practice patterns of iron supplementation on iron metabolism in patients receiving a HIF-PH inhibitor enarodustat. Changes in D-dimer levels, a thrombosis-related factor, were also assessed.

Method

We performed a post-hoc analysis using pooled data from two phase 3 clinical studies of enarodustat in Japanese maintenance hemodialysis patients, SYMPHONY HD and SYMPHONY HD-Long studies. We divided the subjects into three groups according to practice patterns of iron administration: subjects who did not receive iron at all during the enarodustat administration period (Non-Iron Group), subjects who received intravenous iron at least once (IV Iron Group), and subjects who continuously received oral iron-containing preparations including ferric citrate (Oral Iron Group). The time courses of transferrin saturation (TSAT), serum ferritin, and D-dimer levels were compared across these three groups using mixed effects models for repeated measures (MMRM) (with an unstructured covariance structure for the dependent variables).

Results

The Non-Iron Group, IV Iron Group, and Oral Iron Group consisted of 60, 69, and 73 cases, respectively. Figures show the time courses of TSAT, serum ferritin levels, and changes in D-dimer levels for each practice pattern. MMRM analysis revealed that TSAT levels in the Non-Iron Group and IV Iron Group during the enarodustat administration period were significantly lower than those in the Oral Iron Group (p < 0.01 and p < 0.01, respectively). Similar results were observed for serum ferritin levels (p < 0.01 and p < 0.01, respectively). Moreover, the rate of D-dimer increase in the Non-Iron Group was significantly higher than in the Oral Iron Group (p = 0.029). There was a trend toward a higher rate of D-dimer increase in IV Iron Groups compared to the Oral Iron Group (p = 0.11).

Conclusion

These findings suggest the superiority of continuous oral iron supplementation over intermittent IV iron supplementation or no iron supplementation during HIF-PH inhibitor administration in terms of preventing thrombosis through maintaining TSAT levels. The association between iron-related parameters and the occurrence of thrombosis needs to be analyzed.
#1426 Association of intradialytic hypertension and mortality in a cohort of Spanish population
Authors: Mora-Macià Josep , Bello Abraham Rincon , Toro Diana Jc Samaniego , García Macarena Navarro , Ortego Sofia , Pérez Alicia Sobrino , Esquivel Jorge Camilo Morente , García Ramón Polanco , Alvarado Jose Berlanga , Such Ramon Devesa , Salvador Maria Eva Baró
Published: May 2024

Background and Aims

Intradialytic hypertension (IH) has been identified as an independent mortality risk factor in hemodialysis (HD) patients. The are a lack of a standardized definition of (IH).

Recently, a definition of IH ≥30% of baseline sessions with an increase in pre-to post-HD systolic blood pressure (SBP) of ≥10 mmHg had the highest adjusted risk of mortality, compared with other threshold-based definitions (Singh AT, et al. Hypertension 2022;79:855–62) in American population.

The aim of these study is to evaluate this definition of IH in our Spanish population.

Method

We conduct a retrospective multicenter non-interventional study in a Spanish cohort of patients receiving HD (3 sessions PER week) between 1-July 2021 and 30-June 2023 in Fresenius Medical Care Spain. Pre-post-HD SBP, HD parameters and blood test data were averaged over the 90-day exposure period from 1-April-2021 to 30-Jun- 2021. Cox models were fit to examine the association of ID ≥10 mmHg with all-cause mortality in the univariate and multivariate model adjusted for potential confounding variables.

Results

3221 patients met the inclusion criteria, 59.6% men, median age 74 years. The mean of SBP pre HD systolic during the exposure period was 140.6 ± 21 mmHg. The mean follow-up was 22 months. 1620 (50.3%) met the definition of IH,379 (22.4%) of patients with IH died during the follow-up period, compared with 302 of 1587 (19%) individuals who did not meet criteria for IH. In the cox multivariate model, patients with IH, had a significant association with mortality HR: 1.19 [1.01-1.41]) p < 0.05 in a model adjusted for age, Charlson Index, weight loss, vintage, ultrafiltration, vascular access, OL-HDF and malnutrition, among others (Table 1).

Conclusion

Patients with IH (defined as ≥30% of baseline sessions with an increase in pre-to post-HD systolic blood pressure of ≥10 mmHg) have been associated with all-cause mortality (HR 1.19 [1.01-1.41]) in Spanish HD population, similar to previous studies in the American population.
#233 Marine n-3 polyunsaturated fatty acids and cardiovascular events in patients with end-stage renal disease receiving hemodialysis
Authors: Liboriussen Caroline Hundborg , Nygaard Louis , Jensen Jens Dam , Schmidt Erik Berg , Glerup Rie , Svensson My
Published: May 2024

Background and Aims

Cardiovascular (CV) disease is the leading cause of death in patients with end-stage renal disease (ESRD) receiving hemodialysis (HD). The two major marine n-3 polyunsaturated fatty acids (n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may have cardioprotective effects. This study aimed to investigate the predictive value of plasma n-3 PUFAs on CV events and all-cause mortality in patients with ESRD receiving HD.

Method

A validated prospective multicenter cohort study of 336 patients with ESRD receiving HD with 5 years of follow-up was conducted. Blood samples were collected at baseline and analyzed for the plasma levels of EPA and DHA expressed as a weight percentage (wt%) of total plasma fatty acids. The primary outcome was CV events defined as acute myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, peripheral artery disease (PAD), or cardiovascular mortality. The secondary outcomes were all-cause mortality and each individual component of CV events. The sum of EPA and DHA (EPA+DHA) was used in all analyses and expressed as n-3 PUFAs in wt%. The population was divided into three groups according to n-3 PUFA tertiles. Kaplan-Meier curves and multivariable Cox regressions adjusted for relevant confounders were used to analyze the association between plasma n-3 PUFA levels and study outcomes.

Results

Median follow-up time was 5.05 years (IQR, 5.02-5.07). Mean age was 65 ± 15 years and plasma n-3 PUFA levels ranged from 2.1 to 16.8 wt%, with a median of 5.7 wt% (IQR, 4.72-6.96 wt%). During follow-up 60% of the cohort died, 17% died of CV disease, and 42% had a CV event. Figure 1 shows the unadjusted associations between the plasma n-3 PUFA tertiles and the risk of CV events. A n-3 PUFA level between 5.06-6.52 wt% was associated with a 36% lower risk of CV events [unadjusted HR 0.64 (95% CI 0.43-0.96)]. Additionally, a n-3 PUFA level above 6.52 wt% was associated with a 34% lower risk of CV events [unadjusted HR 0.66 (95% CI 0.44-0.98)], both in comparison to levels below 5.06 wt%. After adjusting for relevant confounders, as shown in Figure 2, n-3 PUFA levels between 5.06 to 6.52 wt% were associated with a significantly lower risk of CV events [adjusted HR 0.60 (95% CI 0.40-0.92)], PAD [adjusted HR 0.44 (95% CI 0.22-0.88)], and all-cause mortality [adjusted HR 0.61 (95% CI 0.42-0.86)], when compared to levels below 5.06 wt%.

Conclusion

In this study of patients with ESRD receiving HD, a low plasma level of n-3 PUFA was associated with a higher risk of CV events, peripheral artery disease, and all-cause mortality.
#2652 Hemoglobin excursion outside of the target range and their associations with all-cause mortality in hemodialysis patients
Authors: Mermelstein Ariella , Kovacevic Tomislav , Hymes Jeffrey , Kotanko Peter , Raimann Jochen
Published: May 2024

Background and Aims

Based on earlier analyses (Mermelstein et al., ASN Renal Week 2023), where we found an improved survival with hemoglobin levels above the currently targeted range of 10 to 11 g/dL quantified as an area under the excursion curve, we hypothesized an independent association between all-cause mortality hazard ratio and a) the number of excursions, and b) the number of days outside of the target range.

Method

We explored this relationship in a retrospective cohort study of incident hemodialysis patients receiving erythropoietin stimulating agent (ESA) commencing treatment Fresenius Kidney Care clinics in the US. We included patients who were given a long-acting erythropoietin stimulating agent within 90 days of dialysis initiation, considered the first six months as baseline and the following 18 months as the follow-up period. Only patients with at least 5 hemoglobin values over the first 75 days were included. We calculated the ‘area under the curve’ (AUC) above and below the target hemoglobin range of 10-11 g/dL for each patient during the baseline period, as well as days below and above range, and number of excursions below and above range. Cox proportional hazard models additionally adjusted for age, race, sex, diabetes, serum albumin, and phosphate were developed, and the hazard ratio estimates depicted in a forest plot.

Results

We studied 62,181 patients (57% male, 39% diabetic, mean baseline hgb 10.42 ± 0.72 g/dL, baseline AUC above target 44.36 ± 49.44 g/dL * days and 78.06 ± 86.26 g/dL * days below target). Forest plot of the HR estimates showed an increased risk of death with AUC below the lower limit of the target range (i.e. 10 g/dL), which also held true both for number of excursions and days exposed to lower hgb levels). Conversely, AUC, conversions and days spent at hgb levels higher than the upper limit of the target range (i.e. 11 g/dL), associated with a significant survival advantage.

Conclusion

In an effort to validate the robustness of our previously shown association between higher hgb levels and survival advantage, and to corroborate the accuracy of the utilized AUC quantification method, we separated both components of the AUC, namely into time and magnitude and quantified the independent associations with the risk of death. This allowed to discern between the associations of both to the risk of death. Consistent with the earlier results, avoiding levels below 10 g/dL and aiming for levels above the upper limit of 11 g/dL, seems to be beneficial for the anemia management of incident hemodialysis patients treated with a long-acting ESA.
#849 Association between types of phosphate binders and fragility fractures in patients on hemodialysis
Authors: Fujii Takayuki , Yamauchi Nobuaki , Matsunaga Takahiro , Koshizaka Junya , Morimoto Mayu , Terasaki Noriko , Tanaka Hiroaki , Suzuki Satoshi
Published: May 2024

Background and Aims

Fractures that affect life expectancy and quality of life are an important outcome in patients undergoing hemodialysis. In older patients on dialysis, osteoporosis is particularly associated with fractures. Therefore, management of calcium, parathyroid hormone and phosphorus is essential to promote bone health. However, no effective treatment against osteoporosis has been established in patients with advanced chronic kidney disease Some reports have suggested that the use of calcium-based phosphate binder was favorable in bone metabolism; however, its effect on fragile fractures remains unclear. In this study, we aimed to investigate the relationship between the use of Ca-containing phosphate binders (CPB) or non-Ca-containing phosphate binders (NCPB) and fractures in patients on hemodialysis.

Method

A retrospective cohort study was conducted including 556 patients who started hemodialysis at our hospital between March 2004 and March 2023, and could be followed up for at least 3 months. To assess the association of the use of phosphate binders CPB or NCPB with fragile fractures, a multivariate analysis was performed using the Cox proportional hazard model with factors related to fractures as covariates.

Results

The mean age of the patients was 66 years, with women accounting for 28%. For up to 3 years from hemodialysis initiation, CPB, NCPB, vitamin D receptor activators (VDRA), and calcimimetics were prescribed in 35%, 52%, 72%, and 18% of patients, respectively. Of the 556 patients, 72 developed fragile fractures. A univariate analysis of factors associated with fractures revealed that the hazard ratio (HR) for fragile fractures was 0.39 [0.22-0.64] in CBP users and 0.81 [0.31-0.81] in NCPB users and both were statistically significant fracture suppressors. Multivariate analysis adjusted for significant factors in univariate analysis (age; history of fractures; BMI; levels of serum phosphorus, C-reactive protein, serum magnesium, and hemoglobin; and use or non-use of VDRA) as the covariates, demonstrated that the use of CPB and NCPB was not significantly associated with fractures (HR: 0.58 [0.31–1.05], HR: 0.58 [0.33–1.03]). However, the use of any phosphate binders was a significant fracture preventive factor with an HR of 0.43 [0.24-0.77].

Conclusion

Regarding fragile fractures in patients on hemodialysis, no superiority was observed among CPB and NCPB; however, the use of either phosphate binders could reduce the risk of fragility fracture occurrence.
#2141 Lipoprotein a levels and atherosclerotic cardiovascular disease in hemodialysis patients
Authors: García de la Vega Cristina , Blanco Miguel A , Aguilar José C , Hernández Teresa , Grande Carmen , Quintanilla Nuria , Sánchez José M , Cives Alejandro , García-Bernalt Vanesa , Davín María E , Rocha André , Deira Javier
Published: May 2024

Background and Aims

Lipoprotein a (Lp(a)) is an LDL cholesterol-like particle to which two apolipoprotein(a) molecules are attached. Epidemiological and genetic studies strongly support a causal and continuous association between Lp(a) concentration and atherosclerotic cardiovascular (CV) disease, including aortic valve stenosis, even with low levels of low-density lipoprotein cholesterol. On the other hand, it is well known that patients on hemodialysis (HD) have high comorbidity due to cardiovascular pathology.

Method

We conducted a cross-sectional, observational, retrospective study in a cohort of patients on HD, with the aim of evaluating whether there was any correlation between Lp(a) concentration and atherosclerotic cardiovascular disease (ASCVD).

For this purpose, in December 2023 we measured Lp(a) levels (in nmol/L) in all prevalent HD patients in the province of Cáceres (Spain) and collected their major adverse coronary events (MACE): acute myocardial infarction (AMI) and angina, as well as major adverse non-coronary cardiovascular events (MANCE): cerebrovascular disease and peripheral artery disease. Aortic valve stenosis/calcification was also assessed by echocardiography. SPSS version 21 software was used for statistical analysis.

Results

A total of 214 patients were included, 68.7% male, with a mean age of 70.5 years. The mean Lp(a) value was 76.9 nmol/L, without differences in both sexes. A total of 66.4% had Lp(a) < 75 nmol/L and 23.8% had levels ≥ 125 nmol/L. The main cardiovascular event was peripheral artery disease (14.9%), followed by AMI (14.1%), aortic valve stenosis (10.7%), stroke (8.4%), angina (2.8%) and transient ischemic attack (1.4%).

Some 23.4% (50 patients) had a CV event and, among them, almost half (42%) had Lp(a) levels >75 nmol/L.

A statistically significant linear correlation was found between Lp(a) concentration and AMI (p 0.03) and aortic valve stenosis (p 0.001). No correlation was observed between Lp(a) and the other CV events analyzed (peripheral artery disease, stroke, angina, transient ischemic attack), nor between Lp(a) and sex.

Conclusion

There is a linear and positive correlation between Lp(a) levels and coronary pathology, and with aortic valve stenosis in HD patients in the cohort studied. Studies are needed to assess whether reducing their levels reduces cardiovascular disease in these patients.
#1857 Difelikefalin experience in a large dialysis organization in the US: one year follow-up on patients after completion of 12 weeks
Authors: Ficociello Linda , Lasky Rachel , Arens Hans-Juergen , Budden Jeffery , Ruessmann Despina , Anger Michael
Published: May 2024

Background and Aims

Chronic kidney disease associated pruritis (CKD-aP) is a common disorder that negatively impacts a patient's quality of life. Itch can be self-reported using the Worst Itching Intensity Numerical Rating Scale (WI-NRS) where higher numbers indicate more severe itch. Difelikefalin (DFK) has been shown to reduce itch in hemodialysis (HD) patients with moderate to severe CKD-aP in clinical trials. Previously, we reported the real-world results of patients who completed 12 weeks of DFK treatment as part of routine clinical care. This current analysis describes the long-term treatment of these 295 patients.

Method

Fresenius Kidney Care (FKC) in-center HD patients aged 18-89 who received at least 1 dose of DFK before 15 Nov 2022 and were administered a WI-NRS before first DFK administration were assessed. Patients who received 30+ DFK administrations within 74-84 days were classified as complete and are the focus of this analysis. The current analysis focuses on the 3- to 12-month follow-up after first DFK administration to monitor for DFK discontinuation and severity of itch when DKF therapy is discontinued.

Results

Eighty-one percent of patients (238/295) were administered DFK doses beyond 90 days. These patients treated included 167 patients who received DFK continuously (doses between days 91-101) and 71 who restarted DFK after day 101. Most patients (62%, 148/238) were treated with DKF between days 354 and 365 and 90 (38%, 90/238) stopped before 354 days. Out of those not treated with DFK beyond 90 days (19%, 57/295), 26 patients died or were transferred outside of FKC and 1 received a kidney transplant.

Out of the 84 patients previously reported with WI-NRS measured before DFK and during DFK WI-NRS, 29 had follow up WI-NRS scores during times without DFK doses. We observed a decrease in mean itch severity from 8.0 before DFK to 3.2 during DFK and then a return to higher itch severity after DFK was discontinued (7.3).

Conclusion

In a real-world analysis of patients who completed 12 weeks of DFK therapy, 81% of patients received further DKF administrations. Most patients were treated with DFK between days 354 and 365, although not all patients received continuous DFK therapy. In a subset 29 patients with WI-NRS scores before DFK, during DFK, and after discontinuation, improvements in itch were noted during DFK treatment and a return to severe itch after DFK discontinuation.