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

Heart Failure Clinical Trial

Official title:

Pilot Research Study to Asses Total Body Albumin Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542749
• Other study ID #: DAXOR 01
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: March 1, 2012
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Daxor Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Normal adult males and females.

• Females in the childbearing age group to have test to exclude pregnancy

Exclusion Criteria:

• Children,

• pregnant females

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cirrhosis
• Heart Failure
• Hypoalbuminemia
• Nephrosis
• Shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daxor Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No