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

January 12, 2009 updated by: National Institute of General Medical Sciences (NIGMS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
    • New Jersey
      • Camden, New Jersey, United States
        • Cooper Hospital
    • North Carolina
      • Charlotte, North Carolina, United States
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Procedure: Modified EGDT
Early goal directed therapy with lactate clearance
Active Comparator: 1
Procedure: Standard EGDT
Early goal directed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: In-hospital
In-hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Study Director: Alan E Jones, MD, Carolinas Medical Center
  • Study Chair: Jeffrey A Kline, MD, Carolinas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (Estimate)

September 7, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K23GM076652 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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