Clinical trial NCT05872984: Evaluation of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension
Official title: The Evaluation of the Influence of the Use of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension Associated Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Hypotension During Dialysis
Diagnostic Tests
Keywords: Hemodialysis
Intradialytic hypotension
Intradialytic morbid events
Lead sponsor: HagaZiekenhuis
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consists of the adjustment of the patients' dry weight, based on absolute blood volume measurement. Dry weight will be adjusted at the start of the intervention period in all subjects in the intervention group with a normalized blood volume below 65 ml/kg, regardless the occurrence of intradialytic hypotension associated adverse events during the baseline period. Dry weight will be increased once with 0,5kg.
Primary purpose: DIAGNOSTIC

Brief summary: Establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. Underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. Currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (RBV) measurements, all have their limitations. RBV measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (ABV). Recently, researchers proposed a new method to calculate ABV, by using the principle of dilution-indicator with RBV measurement. In a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms.

The goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. Researchers will compare adjustment of dry weight based on the ABV measurement with standard care to see if dialysis-induced hypotension will be reduced.


Eligibility criteria: Inclusion Criteria:

* hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
* Maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months.
* Hemodialysis scheme three times weekly for four hours
* Age above 18 years.

Exclusion Criteria:

* Clinically relevant fistula dysfunction resulting in single poold Kt/V \<1,2
* Severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician.
* Severe cardiac dysfunction responsible for \>1x intradialytic hypotension associated adverse event /week according to treating physician
* Severe liver failure with or without presence of ascites
* More than three hemodialysis sessions per week
* Single needle treatment
* Central venous access
* Residual diuresis \> 500 ml/ 24h
* Inability to provide informed consent

Primary outcomes:
measure: difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group
timeFrame: 10 weeks
Secondary outcomes:
measure: Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.
timeFrame: baseline
measure: Reproducibility of absolute blood volume measurement
timeFrame: 2 weeks
measure: Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume
timeFrame: 2 weeks
measure: Sensitivity, specificity
timeFrame: 10 weeks
measure: positive predictive value, negative predictive value
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
Study officials:
affiliation: HagaZiekenhuis
name: Louis Jean Vleming, dr
role: PRINCIPAL_INVESTIGATOR
References: