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

HagaZiekenhuis

Status: Completed

Conditions: Hemodialysis Complication; Diagnostic Tests; Hypotension During Dialysis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05872984

NL71892.058.19

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Control arm: standard care

No Intervention group

Description:

standard care provided by the clinician, no intervention.