Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation (LactATES)

This study has been completed.
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00372502
First received: September 6, 2006
Last updated: January 12, 2009
Last verified: January 2009

September 6, 2006
January 12, 2009
January 2007
December 2008   (final data collection date for primary outcome measure)
Mortality [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
In-hospital mortality
Complete list of historical versions of study NCT00372502 on ClinicalTrials.gov Archive Site
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Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial

The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • Procedure: Modified EGDT
    Early goal directed therapy with lactate clearance
  • Procedure: Standard EGDT
    Early goal directed therapy
  • Active Comparator: 1
    Intervention: Procedure: Standard EGDT
  • Experimental: 2
    Intervention: Procedure: Modified EGDT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Suspected infection
  2. Any two of four criteria of systemic inflammatory response
  3. SBP < 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate > 4 mmol/L (severe sepsis).

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnancy
  3. Established "Do Not Resuscitate" orders prior to enrollment
  4. Primary diagnosis other than sepsis
  5. Requirement for immediate surgery in < 6 hours from admission
  6. Any absolute contraindication to central venous catheterization
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00372502
1K23GM076652
Yes
Alan E Jones, MD; Assistant Research Director, Carolinas Medical Center
National Institute of General Medical Sciences (NIGMS)
Not Provided
Study Director: Alan E Jones, MD Carolinas Medical Center
Study Chair: Jeffrey A Kline, MD Carolinas Medical Center
National Institute of General Medical Sciences (NIGMS)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP