Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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: NCT00372502
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : January 14, 2009
Information provided by:
National Institute of General Medical Sciences (NIGMS)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Procedure: Modified EGDT Procedure: Standard EGDT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial
Study Start Date : January 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: 1 Procedure: Standard EGDT
Early goal directed therapy

Experimental: 2 Procedure: Modified EGDT
Early goal directed therapy with lactate clearance

Primary Outcome Measures :
  1. Mortality [ Time Frame: In-hospital ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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): NCT00372502

Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
United States, New Jersey
Cooper Hospital
Camden, New Jersey, United States
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Layout table for investigator information
Study Director: Alan E Jones, MD Carolinas Medical Center
Study Chair: Jeffrey A Kline, MD Carolinas Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alan E Jones, MD; Assistant Research Director, Carolinas Medical Center Identifier: NCT00372502    
Other Study ID Numbers: 1K23GM076652 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009
Keywords provided by National Institute of General Medical Sciences (NIGMS):
emergency department
Additional relevant MeSH terms:
Layout table for MeSH terms
Systemic Inflammatory Response Syndrome
Pathologic Processes