NCT01679249

Blood Volume Analysis and Related Outcomes in Hemodialysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: VA New York Harbor Healthcare System · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Kidney Disease

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-09-05
• Last updated: 2012-09-10

Locations

1 site across 1 country: United States