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

This study has been completed.
Sponsor:
Collaborators:
Medical Center Rijnmond Zuid, Rotterdam
Sint Franciscus Gasthuis
Reinier de Graaf Hospital, Delft
Albert Schweitzer Hospital
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00270673
First received: December 23, 2005
Last updated: April 24, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Tissue Hypoxia
Hyperlactatemia
Procedure: Early lactate-directed therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Lactate-Directed Therapy on the ICU: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • In-hospital mortality

Secondary Outcome Measures:
  • ICU mortality
  • Day-28 mortality
  • APACHE II,SOFA and hemodynamic variables
  • Use of health care resources
  • Pre-specified subgroup analyses within non-sepsis stratum:
  • Neuro critical care (traumatic brain injury, neurovascular conditions, neuro-oncological conditions)
  • Cardiac arrest
  • Remaining group (without neuro critical care and cardiac arrest)
  • Pre-specified subgroup analyses within sepsis stratum:
  • Sepsis and severe sepsis
  • Septic shock

Estimated Enrollment: 350
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270673

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00270673     History of Changes
Other Study ID Numbers: 2005-334
Study First Received: December 23, 2005
Last Updated: April 24, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 29, 2014