Clinical trial NCT03910426: Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients
Official title: Prognostic Determinants (Nutritional Versus Functional Versus Biochemical) of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients Treated With Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis
Quality of Life
Nutrition
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2019-04-10
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients treated with dialysis were eligible for inclusion

Brief summary: Patients with end-stage kidney disease are treated with dialysis to increase their life expectancy as well as their quality of life (QoL). Scientific researchers are currently still looking for markers to evaluate dialysis in an objective way. It has been proven before that the currently clinically used parameters (like the dialysis adequacy parameter Kt/V) are not appropriate enough to estimate dialysis dose.

The current project aims at identifying potential (predicting) biomarkers based on functional capacity, nutritional status and/or QoL.

Detailed description: This multisite study is an observational study during which prevalent dialysis patients are followed during maximum 3 years, and they undergo different tests.

Once a year (max 3 times), blood is sampled, stool is collected, and finger nails are taken all before a midweek session. Demographic data are registered and Davies-Stokes scores are calculated. Blood is analysed for different solutes: e.g. total and free fractions of protein-bound toxins, sedimentation, erythrocytes, hematocrit, leukocytes, thrombocytes, Ferritin, VitB12, Fasting glucose, c-reactive protein, urea, creatinine, albumin, total protein, cholesterol, triglycerides, bilirubin,...

At the same occasion, patients are questioned about different items (QoL, nutrition) by a (study) nurse or coordinator, using different questionnaires: Euroqol 5 dimension scale (EQ-5D), Patient-Reported Outcomes Measurement Information System (Promis-29), and Mini Nutritional Assessment (MNA).

A subgroup of patients were asked to perform some functional tests: Tinetti-Test, Sit to Stand (5 times), Frailty and Injuries: Cooperative Studies on Intervention Techniques (Ficsit) test, 2 or 6 minutes walking test, handgrip strength and quadriceps power measurement, back scratch test, compensatory stepping correction-backward test and skin fold measurement. All tests are non-invasive and are validated for routine measurements in the elderly.

In order to quantify sleep, patients were asked to wear a Motionwatch (Actigraphy) to register their arm movements during 2 or 3 nights as well as to fill out 2 questionnaires related to sleep: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). To compare sleep in dialysis patients with healthy persons, age and gender matched healthy volunteers were also included in the study and were asked to sleep 2 or 3 nights with the Motionwatch and to complete the ISI and PSQI.

Patients who were transplanted got an extra blood sampling just before transplantation as well as 4 months after transplantation.

Eligibility criteria: Inclusion Criteria:

- end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis)

Exclusion Criteria:

* active inflammation
* malignancy
* cognitive disorder
* not understanding the dutch language

Primary outcomes:
measure: Correlation between protein-bound uremic toxin concentrations and physical parameter 6 minute walking test (6MWT)
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and physical parameter sit-to-stand test
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and muscle strength
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and risk of fall
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and nutritional status
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and quality of life (EQ-5D)
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and quality of life (Promis)
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (sleep efficiency)
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and objective sleep parameter (fragmentation index)
timeFrame: 10/2015 - 12/2018
measure: Correlation between protein-bound uremic toxin concentrations and patient survival
timeFrame: 10/2015 - 12/2018
Secondary outcomes:
Other outcomes:
measure: Difference between objectively measured sleep quality (sleep efficiency) in dialysis patients versus healthy controls
timeFrame: 2016-2018
measure: Difference between objectively measured sleep quality (fragmentation index) in dialysis patients versus healthy controls
timeFrame: 2016-2018
measure: Difference between subjectively measured sleep quality (ISI) in dialysis patients versus healthy controls
timeFrame: 2016-2018
measure: Difference between subjectively measured sleep quality (PSQI) in dialysis patients versus healthy controls
timeFrame: 2016-2018
measure: Difference between the MNA scores for the short form (screening score) and the MNA score of the full form (indication score)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and physical parameter 6 minute walking test (6MWT)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and physical parameter 6 minute walking test (6MWT)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and physical parameter sit-to-stand test
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and physical parameter sit-to-stand test
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and muscle strength
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and muscle strength
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and risk of fall
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and risk of fall
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and nutritional status
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and nutritional status
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (sleep efficiency)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and the objective sleep parameter (sleep efficiency)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (EQ-5D) and the objective sleep parameter (fragmentation index)
timeFrame: 10/2015-12/2018
measure: Correlation between subjective QoL score (Promis) and the objective sleep parameter (fragmentation index)
timeFrame: 10/2015-12/2018
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Wim Van Biesen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanden Wyngaert K, Celie B, Calders P, Eloot S, Holvoet E, Van Biesen W, Van Craenenbroeck AH. Markers of protein-energy wasting and physical performance in haemodialysis patients: A cross-sectional study. PLoS One. 2020 Jul 30;15(7):e0236816. doi: 10.1371/journal.pone.0236816. eCollection 2020.