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
  Purpose

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 Intervention
Severe Sepsis
Septic Shock
Procedure: Modified EGDT
Procedure: Standard EGDT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Mortality [ Time Frame: In-hospital ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Standard EGDT
Early goal directed therapy
Experimental: 2 Procedure: Modified EGDT
Early goal directed therapy with lactate clearance

  Eligibility

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

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
  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: NCT00372502

Locations
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
Investigators
Study Director: Alan E Jones, MD Carolinas Medical Center
Study Chair: Jeffrey A Kline, MD Carolinas Medical Center
  More Information

Additional Information:
No publications provided by National Institute of General Medical Sciences (NIGMS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan E Jones, MD; Assistant Research Director, Carolinas Medical Center
ClinicalTrials.gov Identifier: NCT00372502     History of Changes
Other Study ID Numbers: 1K23GM076652
Study First Received: September 6, 2006
Last Updated: January 12, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
sepsis
shock
emergency department
resuscitation

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on September 16, 2014