Effects of Storage on Lactate in Blood Samples
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00011050|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 30, 2008
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||13 participants|
|Official Title:||Effects of Storage on Plasma Lactate Determinations|
|Study Start Date :||January 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011050
|United States, California|
|UCSF - San Francisco Gen Hosp|
|San Francisco, California, United States, 94110|
|United States, Indiana|
|Indiana Univ Hosp|
|Indianapolis, Indiana, United States, 462025250|
|Division of Inf Diseases/ Indiana Univ Hosp|
|Indianapolis, Indiana, United States, 46202|
|Study Chair:||Michael Dube|
|Study Chair:||Kathleen Mulligan|