Evaluation of Total Blood Volume Measurement During Dialysis on the Incidence of Intradialytic Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2023-01-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemodialysis Complication Hypotension During Dialysis Diagnostic Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Both the patients and the clinicians involved in patient care were not aware of the results of the absolute blood volume measurements.

Study Groups

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Intervention arm: adjustment of 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 adjusted once with 0,5kg.

Group Type EXPERIMENTAL

adjustment of dry weight based on absolute blood volume measurement

Intervention Type DIAGNOSTIC_TEST

adjustment of dry weight based on absolute blood volume measurement

Control arm: standard care

standard care provided by the clinician, no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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adjustment of dry weight based on absolute blood volume measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No