Early Lactate-Directed Therapy in the Intensive Care Unit (ICU)

NCT00270673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2008-04-25

No results posted yet for this study

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).

Conditions

  • Tissue Hypoxia
  • Hyperlactatemia

Interventions

PROCEDURE

Early lactate-directed therapy

Sponsors & Collaborators

  • Medical Center Rijnmond Zuid, Rotterdam

    collaborator UNKNOWN
  • Sint Franciscus Gasthuis

    collaborator OTHER
  • Reinier de Graaf Groep

    collaborator OTHER
  • Albert Schweitzer Hospital, Netherlands

    collaborator UNKNOWN
  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Jan Bakker, MD, PhD · Erasmus MC University Medical Center Rotterdam

  • Tim C Jansen, MD · Erasmus MC University Medical Center Rotterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270673 on ClinicalTrials.gov