Effects of Storage on Lactate in Blood Samples - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00011050

Purpose

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
HIV Infections

Study Type:	Observational
Official Title:	Effects of Storage on Plasma Lactate Determinations

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	13
Study Start Date:	January 2001

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011050

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Michael Dube
Study Chair:	Kathleen Mulligan

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ACTG A5099, AACTG A5099
Study First Received:	February 9, 2001
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00011050 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Specimen Handling
Blood
Cryopreservation

Lactic Acid
Sodium Fluoride
Oxalates

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 22, 2009