Blood Volume Analysis and Related Outcomes in Hemodialysis
|ClinicalTrials.gov Identifier: NCT01679249|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 10, 2012
|Condition or disease|
|End Stage Kidney Disease|
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 Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Blood Volume Analysis and Related Outcomes in Hemodialysis|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Stable prevalent patients on 3-times-per-week hemodialysis
- Blood volume measurement and comparison to Crit-Line reading [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679249
|United States, New York|
|New York Harbor VA Healthcare System Hemodialysis Unit|
|New York, New York, United States, 10010|
|Principal Investigator:||David S Goldfarb, MD||VA New York Harbor Healthcare System|