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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270673
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : April 25, 2008
Medical Center Rijnmond Zuid, Rotterdam
Sint Franciscus Gasthuis
Reinier de Graaf Hospital, Delft
Albert Schweitzer Hospital
Information provided by:
Erasmus Medical Center

Brief 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).

Condition or disease Intervention/treatment Phase
Tissue Hypoxia Hyperlactatemia Procedure: Early lactate-directed therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Lactate-Directed Therapy on the ICU: A Randomized Controlled Trial
Study Start Date : February 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. In-hospital mortality

Secondary Outcome Measures :
  1. ICU mortality
  2. Day-28 mortality
  3. APACHE II,SOFA and hemodynamic variables
  4. Use of health care resources
  5. Pre-specified subgroup analyses within non-sepsis stratum:
  6. Neuro critical care (traumatic brain injury, neurovascular conditions, neuro-oncological conditions)
  7. Cardiac arrest
  8. Remaining group (without neuro critical care and cardiac arrest)
  9. Pre-specified subgroup analyses within sepsis stratum:
  10. Sepsis and severe sepsis
  11. Septic shock

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients admitted to the general ICU with an admission lactate level of ≥ 3,0 mmol/l
  • Written informed consent

Exclusion Criteria:

  • Liver failure
  • Post liver surgery
  • Age < 18 years
  • Do not resuscitate status
  • Contraindication to central venous or arterial catheterization
  • Epileptic seizures (shortly before or during admission)
  • Evident aerobic cause of hyperlactatemia
  • Judgement of treating physician that study participation is undesirable for medical, medical-ethical or other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270673

Reinier de Graaf Hospital
Delft, Netherlands
Erasmus MC University Medical Center
Rotterdam, Netherlands
Ikazia Hospital
Rotterdam, Netherlands
Medical Center Rijnmond Zuid
Rotterdam, Netherlands
St. Fransiscus Gasthuis
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Medical Center Rijnmond Zuid, Rotterdam
Sint Franciscus Gasthuis
Reinier de Graaf Hospital, Delft
Albert Schweitzer Hospital
Study Chair: Jan Bakker, MD, PhD Erasmus MC University Medical Center Rotterdam
Principal Investigator: Tim C Jansen, MD Erasmus MC University Medical Center Rotterdam


Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00270673     History of Changes
Other Study ID Numbers: 2005-334
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by Erasmus Medical Center:
Tissue hypoxia
Intensive care
Goal- directed therapy

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms
Metabolic Diseases