Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daxor Corporation
ClinicalTrials.gov Identifier:
NCT01542749
First received: February 27, 2012
Last updated: March 1, 2012
Last verified: February 2012
  Purpose

The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.


Condition
Hypoalbuminemia
Heart Failure
Nephrosis
Cirrhosis
Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Research Study to Asses Total Body Albumin Levels

Resource links provided by NLM:


Further study details as provided by Daxor Corporation:

Primary Outcome Measures:
  • Total Body Albumin [ Designated as safety issue: No ]
    The study demonstrated that total body albumin can be determined utilizing modified software designed for this purpose with the BVA 100 blood volume analyzer


Enrollment: 20
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Twenty adult individuals underwent a standard blood volume measurement. The specimens for this determination are normally collected over a period of approximately 40 minutes. For the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. Calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. The ratio of albumin in the intravascular to the extravascular space is available in the medical literature. The total volume in which the tracer is distributed can be determined from the dilution determined. A calculation of total body albumin is therefore possible. Computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. The purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult male and female volunteers

Criteria

Inclusion Criteria:

  • Normal adult males and females.
  • Females in the childbearing age group to have test to exclude pregnancy

Exclusion Criteria:

  • Children,
  • pregnant females
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01542749

Sponsors and Collaborators
Daxor Corporation
Investigators
Principal Investigator: Joseph Feldschuh, MD Daxor Corporation
  More Information

No publications provided

Responsible Party: Daxor Corporation
ClinicalTrials.gov Identifier: NCT01542749     History of Changes
Other Study ID Numbers: DAXOR 01
Study First Received: February 27, 2012
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Daxor Corporation:
BVA-100 Blood volume analyzer
Human serum albumin labeled with Iodine 131

Additional relevant MeSH terms:
Heart Failure
Liver Cirrhosis
Fibrosis
Nephrosis
Shock
Hypoalbuminemia
Heart Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014