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Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

NCT00372502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-01-14

No results posted yet for this study

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.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

PROCEDURE

Modified EGDT

Early goal directed therapy with lactate clearance

PROCEDURE

Standard EGDT

Early goal directed therapy

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    lead NIH

Principal Investigators

  • Alan E Jones, MD · Carolinas Medical Center

  • Jeffrey A Kline, MD · Carolinas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00372502 on ClinicalTrials.gov