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

NCT00270673 | Completed Phase 3 DMC

• 1 other identifier: 2005-334
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 5

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).

Conditions

Tissue Hypoxia; Hyperlactatemia

Keywords

Lactate; Tissue hypoxia; Intensive care; Goal- directed therapy

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

Secondary Outcomes (11)

• ICU mortality

• Day-28 mortality

• APACHE II,SOFA and hemodynamic variables

• Use of health care resources

• Pre-specified subgroup analyses within non-sepsis stratum:

Interventions

Early lactate-directed therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Medical Center Rijnmond Zuid, Rotterdam: collaborator
• Sint Franciscus Gasthuis: collaborator
• Reinier de Graaf Groep: collaborator
• Albert Schweitzer Hospital, Netherlands: collaborator

Study Sites (5)

Reinier de Graaf Hospital

Delft, Netherlands

Location

Erasmus MC University Medical Center

Rotterdam, Netherlands

Location

Ikazia Hospital

Rotterdam, Netherlands

Location

Medical Center Rijnmond Zuid

Rotterdam, Netherlands

Location

St. Fransiscus Gasthuis

Rotterdam, Netherlands

Location

Related Publications (15)

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• Rossi AF, Khan DM, Hannan R, Bolivar J, Zaidenweber M, Burke R. Goal-directed medical therapy and point-of-care testing improve outcomes after congenital heart surgery. Intensive Care Med. 2005 Jan;31(1):98-104. doi: 10.1007/s00134-004-2504-1. Epub 2004 Dec 1.

  PMID: 15650863 BACKGROUND

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• Levy B, Gibot S, Franck P, Cravoisy A, Bollaert PE. Relation between muscle Na+K+ ATPase activity and raised lactate concentrations in septic shock: a prospective study. Lancet. 2005 Mar 5-11;365(9462):871-5. doi: 10.1016/S0140-6736(05)71045-X.

  PMID: 15752531 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

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  PMID: 12373469 BACKGROUND

• Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.

  PMID: 20463176 DERIVED

MeSH Terms

Conditions

Hyperlactatemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Bakker, MD, PhD

  Erasmus MC University Medical Center Rotterdam

  STUDY CHAIR

• Tim C Jansen, MD

  Erasmus MC University Medical Center Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 28, 2005
• Study Start: February 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 25, 2008

Record last verified: 2008-04

Locations

NL (5)