Blood Volume Analysis and Related Outcomes in Hemodialysis

End Stage Kidney Disease Clinical Trial

Official title:

Blood Volume Analysis and Related Outcomes in Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679249
• Other study ID #: 01249
• Status: Completed
• Phase: N/A
• First received: August 31, 2012
• Last updated: September 6, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: VA New York Harbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 (?RBV)

• 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	New York Harbor VA Healthcare System Hemodialysis Unit	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA New York Harbor Healthcare System	Daxor Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood volume measurement and comparison to Crit-Line reading	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.	Six months	No