Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

Completed · Not applicable

Conditions studied: Severe Sepsis, Septic Shock

In brief

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.

Key facts

Study ID: NCT00372502
Run by: National Institute of General Medical Sciences (NIGMS)
People needed: 300
Starts: 2007-01-01
Expected to finish: 2008-12-01
Last updated by the study team: 2009-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Suspected infection
Any two of four criteria of systemic inflammatory response
SBP < 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate > 4 mmol/L (severe sepsis).

You may not qualify if…

Age < 18 years
Pregnancy
Established "Do Not Resuscitate" orders prior to enrollment
Primary diagnosis other than sepsis
Requirement for immediate surgery in < 6 hours from admission
Any absolute contraindication to central venous catheterization

Where it is running

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

Full record on ClinicalTrials.gov

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