Effects of Storage on Lactate in Blood Samples
Primary Purpose
HIV Infections
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for HIV Infections focused on measuring Specimen Handling, Blood, Cryopreservation, Lactic Acid, Sodium Fluoride, Oxalates
Eligibility 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.
Sites / Locations
- UCSF - San Francisco Gen Hosp
- Indiana Univ Hosp
- Division of Inf Diseases/ Indiana Univ Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00011050
First Posted
February 9, 2001
Last Updated
July 29, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00011050
Brief Title
Effects of Storage on Lactate in Blood Samples
Official Title
Effects of Storage on Plasma Lactate Determinations
Study Type
Observational
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Specimen Handling, Blood, Cryopreservation, Lactic Acid, Sodium Fluoride, Oxalates
7. Study Design
Enrollment
13 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dube
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kathleen Mulligan
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Division of Inf Diseases/ Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Storage on Lactate in Blood Samples
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