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Effects of Storage on Lactate in Blood Samples

NCT ID: NCT00011050

Last Updated: 2008-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Specimen Handling Blood Cryopreservation Lactic Acid Sodium Fluoride Oxalates

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Michael Dube

Role: STUDY_CHAIR

Kathleen Mulligan

Role: STUDY_CHAIR

Locations

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UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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AACTG A5099

Identifier Type: -

Identifier Source: secondary_id

ACTG A5099

Identifier Type: -

Identifier Source: org_study_id