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Blood Volume Analysis and Related Outcomes in Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
David S. Goldfarb, M.D., VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01679249
First received: August 31, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
End Stage Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Volume Analysis and Related Outcomes in Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA New York Harbor Healthcare System:

Primary Outcome Measures:
  • Blood volume measurement and comparison to Crit-Line reading [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis patients
Stable prevalent patients on 3-times-per-week hemodialysis

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the pool of patients at the Dialysis Center at the Department of Veteran Affairs New York Harbor Healthcare System who are currently undergoing dialysis for treatment of chronic kidney disease.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679249

Locations
United States, New York
New York Harbor VA Healthcare System Hemodialysis Unit
New York, New York, United States, 10010
Sponsors and Collaborators
VA New York Harbor Healthcare System
Daxor Corporation
Investigators
Principal Investigator: David S Goldfarb, MD VA New York Harbor Healthcare System
  More Information

No publications provided

Responsible Party: David S. Goldfarb, M.D., Chief, Nephrology, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT01679249     History of Changes
Other Study ID Numbers: 01249
Study First Received: August 31, 2012
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by VA New York Harbor Healthcare System:
extracellular fluid volume
hypotension
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013