The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years. Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test...
Date First Received: February 9, 2001
Last Updated: July 29, 2008
Verified by: National Institute of Allergy and Infectious Diseases (NIAID), November 2004
Clinical Trial Phase: N/A | Start Date: January 2001
Overall Status: Completed
Estimated Enrollment: 13
Brief Summary
Official Title: “Effects of Storage on Plasma Lactate Determinations”
Condition Keyword(s):
The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years.
Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test lactate levels.
Study Type: Observational
Study Design: N/A
Detailed Clinical Trial Description
Lactic acidosis syndrome is a complication of therapy with nucleoside reverse transcriptase inhibitor (NRTI) drugs. Measurement of lactate levels is important in clinical trials of antiretroviral treatments. The preferred collection method for determining plasma lactate is with NaF/KOx tubes, while a number of ACTG studies have stored blood in ethylenediaminetetraacetic acid (EDTA) tubes. This study will analyze lactate in samples collected and stored in NaF/KOx and EDTA tubes to investigate the reliability of lactate concentrations over time.
Pre- and post-exercise blood samples are drawn from participants into NaF/KOx and EDTA tubes and a portion is tested for lactate levels immediately. The remaining portions are frozen and tested at 1, 3, 6, 12, 18, 24, and 36 months.
Criteria for Participation in this Clinical Trial
Inclusion Criteria
Participants may be eligible for this study if they:
- Are at least 18 years old.
- Have sufficient forearm veins.
Exclusion Criteria
Participants will not be eligible for this study if they:
- Have a physical disability that prevents forearm exercise.
- Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Clinical Trial Officials and Contacts
Michael Dube Study Chair
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00011050
Study ID Number: ACTG A5099
ClinicalTrials.gov Identifier: NCT00011050
Health Authority: United States: Federal Government
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