Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

Not Applicable

Completed

• Conditions: Severe Sepsis; Septic Shock
• Interventions: Procedure: Standard EGDT; Procedure: Modified EGDT

• Registration Number: NCT00372502
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Study Start: 2007-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard EGDT	-
2	Modified EGDT	-

Primary Outcome Measures

Name	Time	Method
Mortality	In-hospital

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cooper Hospital; 🇺🇸 Camden, New Jersey, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States