Viewing Study NCT00011050



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Study NCT ID: NCT00011050
Status: COMPLETED
Last Update Posted: 2008-07-30
First Post: 2001-02-09

Brief Title: Effects of Storage on Lactate in Blood Samples
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Effects of Storage on Plasma Lactate Determinations
Status: COMPLETED
Status Verified Date: 2004-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 NaFKOx 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 NaFKOx and EDTA tubes to investigate the reliability of lactate concentrations over time

Pre- and post-exercise blood samples are drawn from participants into NaFKOx 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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
AACTG A5099 None None None