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

NCT05872984 | Completed DMC

• 1 other identifier: NL71892.058.19
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Hypotension During Dialysis; Diagnostic Tests

Keywords

Hemodialysis; Intradialytic hypotension; Intradialytic morbid events

Outcome Measures

Primary Outcomes (1)

• difference in the incidence of intradialytic hypotension-associated adverse events between the intervention and control group

  The incidence of intradialytic hypotension-associated adverse events (IHAAE) will be compared at baseline and after intervention, using questionnaires. Participants will undergo a 4-week run-in period to assess baseline incidence. The incidence of IHAAE will be calculated by dividing the number of dialysis treatments with one or more symptoms attributable to IHAAE as a percentage of the total number of dialysis treatments with a completed questionnaire. After randomization and the intervention, the occurence of IHAAE will be measured in both arms for another four weeks. Differences in incidence of IHAAE between groups will be analyzed using ANCOVA, adjusting for baseline IHAAE, pre-dialysis blood pressure and the use of anti-hypertensive agents. IHAAE is defined as a systolic blood pressure \< 90 mmHg Either symptomatic or asymptomatic, or solely symptoms associated to (impeding) hypotension like dizziness, lightheadedness, sweating, cramps or visuel disturbances.

  10 weeks

Secondary Outcomes (5)

• Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.

  baseline

• Reproducibility of absolute blood volume measurement

  2 weeks

• Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume

  2 weeks

• Sensitivity, specificity

  10 weeks

• positive predictive value, negative predictive value

  10 weeks

Study Arms (2)

Intervention arm: adjustment of dry weight based on absolute blood volume measurement

EXPERIMENTAL

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.

Diagnostic Test: adjustment of dry weight based on absolute blood volume measurement

Control arm: standard care

NO INTERVENTION

standard care provided by the clinician, no intervention.

Interventions

adjustment of dry weight based on absolute blood volume measurement DIAGNOSTIC_TEST

adjustment of dry weight based on absolute blood volume measurement

Intervention arm: adjustment of dry weight based on absolute blood volume measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemodialysis patients of three dialysis locations of the Haga Hospital (Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
• Hemodialysis scheme three times weekly for four hours
• Age above 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• HagaZiekenhuis: lead

Study Sites (1)

HagaZiekenhuis

The Hague, 2545 AA, Netherlands

Location

Study Officials

• Louis Jean Vleming, dr

  HagaZiekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both the patients and the clinicians involved in patient care were not aware of the results of the absolute blood volume measurements.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. LJ Vleming

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 24, 2023
• Study Start: July 9, 2020
• Primary Completion: May 31, 2021
• Study Completion: January 17, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)