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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pilot Research Study to Asses Total Body Albumin Levels

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Daxor Corporation

Current Primary Outcome: Total Body Albumin

The study demonstrated that total body albumin can be determined utilizing modified software designed for this purpose with the BVA 100 blood volume analyzer


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Daxor Corporation

Dates:
Date Received: February 27, 2012
Date Started: January 2009
Date Completion:
Last Updated: March 1, 2012
Last Verified: February 2012