Blood Volume Analysis and Related Outcomes in Hemodialysis

Completed

• Conditions: End Stage Kidney Disease

• Registration Number: NCT01679249
• Lead Sponsor: VA New York Harbor Healthcare System

Brief Summary

An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration (UF) is essential for determining the efficacy of HD, as well as for reducing complications related to hypovolemia or, conversely, chronic volume overload.

Detailed Description

Background: Accurate assessment of the BV and distribution of body fluids is essential for prescribing HD and for reducing complications related to hypovolemia and volume overload. Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method, cannot be used to determine the absolute levels of BV. Here we report the first study of isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator dilutional method.

10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV with an accuracy of ±2.5%, by using \<25μCi of iodinated I-131 albumin. It assumes normal BV for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss from the extravascular component of the extracellular space (EV) was calculated by subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were measured by CLM-III during the same HD session. Bland-Altman plot was used to compare relative BV change pre- and post-HD by IBVM and CLM-III.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-08-31
• Status Verified: 2012-09
• Study First Posted: 2012-09-05
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age >21 years
• Primary diagnosis of either chronic or acute kidney disease
• Currently receiving HD treatment
• Thrice-weekly or twice-weekly HD schedule
• Treated with standard bicarbonate HD for at least the preceding 6 months

Exclusion Criteria

• Pregnant women or nursing mothers
• Known hypersensitivity to iodine, eggs, albumin or any other component of the Volumex injection kit
• Current enrollment in another investigational treatment protocol for dialysis
• The need to perform hemodialysis with predilution because this will interfere with measurements of relative blood volume changes (ΔRBV)
• Kidney transplantation
• Malignancy requiring chemotherapy
• Unmeasurable blood pressure with a sphygmomanometer
• Active hematological disease
• Active gastrointestinal bleeding
• Severe malnutrition (predialysis serum albumin <2.6 g/dL)
• Persistent condition of intradialytic blood pressure instability (hypotensive episodes in >80% of regular dialysis sessions) within the previous one month period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood volume measurement and comparison to Crit-Line reading	Six months	To compare the results obtained by two different methods of assessing BV: direct measurement of BV using the Blood Volume Analyzer (BVA-100) vs. indirect measurement of relative changes in BV using the Crit-Line Monitor (CLM III). Blood volume is measured in liters and compared with "ideal blood volume" nomograms. Crit-Line Monitor measures relative change in blood volume as a percentage change and does not have absolute values.

Trial Locations

Locations (1)

New York Harbor VA Healthcare System Hemodialysis Unit; 🇺🇸 New York, New York, United States