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

Hemodialysis Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05872984
• Other study ID #: NL71892.058.19
• Status: Completed
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: January 17, 2023

Study information

• Verified date: May 2023
• Source: HagaZiekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 17, 2023
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hypotension
• Hypotension During Dialysis

Intervention

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

Locations

Country	Name	City	State
Netherlands	HagaZiekenhuis	Den Haag

Sponsors (1)

Lead Sponsor	Collaborator
HagaZiekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline incidence of intradialytic hypotension associated adverse events (IHAAE) in the entire study population.	Eligible participants will undergo a 4-week run-in period to assess baseline incidence of IHAAE, using questionnaires.; 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 by the total number of dialysis treatments with a completed questionnaire.	baseline
Secondary	Reproducibility of absolute blood volume measurement	Absolute blood volume (ABV) will be measured twice in the entire study population, at the start of two mid-weekly hemodialysis treatments.; We will investigate the correlation between these two test results, using Bland Altman Analysis.	2 weeks
Secondary	Correlation of absolute blood volume measurement with other diagnostic tests to determine blood volume	We will calculate antropomorphic blood volume in the whole study population, using the Nadler's formula.; We will randomly select 10 participants for ABV measurement with the reference method.This technique is based on the isotope-dilution principal using I-251 radiolabeled human serum albumin. Adverse events due to the infusion of radioactive labelled albumin are very rare (0.01-0.1%, <0.01 % anaphylactic reactions). For a 70kg-patient the dose will be 0,02 millisievert. This falls within risk category I according to the International Commission on Radiological Protection (ICRP). This is the lowest risk category with a statistical probability of less than five in a million to develop radiation induced cancer. Annual background radiation level in the Netherlands is about 2,5 mSv.; We will correlate the results of these diagnostic tests to our ABV measurement, using Bland Altman analysis.	2 weeks
Secondary	Sensitivity, specificity	We will use the values of absolute volume measurement and incidence of IHAAE to calculate sensitivity, specificity of the previously defined critical threshold of normalized blood volume of 65 ml/kg for the occurrence of IHAAE.	10 weeks
Secondary	positive predictive value, negative predictive value	We will use the values of absolute volume measurement and incidence of IHAAE to calculate positive and negative predictive value of the previously defined critical threshold of normalized blood volume of 65 ml/kg for the occurrence of IHAAE.	10 weeks