CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 target
Drug / intervention
Early lactate-directed therapyprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00270673
NCT00270673Phase 3Completed

Early Lactate-Directed Therapy on the ICU: A Randomized Controlled Trial

Erasmus Medical Center·interventional·Posted Dec 28, 2005·Updated Apr 25, 2008

In Brief

A Phase 3 clinical trial evaluating Early lactate-directed therapy for Tissue Hypoxia and Hyperlactatemia. Completed, enrolled 350 participants across 5 sites.

Detailed Summary

Blood lactate levels have long been related to tissue hypoxia, a severe condition in critically ill patients associated with the development of organ system failure and subsequent death. Increased blood lactate levels and failure to normalize blood lactate levels during treatment have been associated with increased morbidity and mortality. However, evidence of improved clinical outcome of lactate-directed therapy is limited and difference in the use of blood lactate monitoring in the intensive care unit exists between hospitals. This warrants a study on the efficacy of early blood lactate-directed therapy. In this study the efficacy of 8 hours of early lactate-directed therapy (therapy aimed at resolving tissue hypoxia that is guided by serial blood lactate levels) will be compared with 8 hours of control group therapy (without lactate measurement).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2005
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.5 years ago

Interventions

Early lactate-directed therapyprocedure