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Effects of Storage on Lactate in Blood Samples

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00011050
First received: February 9, 2001
Last updated: July 29, 2008
Last verified: November 2004
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Sponsors and Collaborators
Investigators
Study Chair: Michael Dube
Study Chair: Kathleen Mulligan
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00011050     History of Changes
Other Study ID Numbers: ACTG A5099, AACTG A5099
Study First Received: February 9, 2001
Last Updated: July 29, 2008
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014