Status:
COMPLETED
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Sepsis
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether inhaled nitric oxide is an effective treatment for microcirculatory dysfunction and acute organ system failure in the early stage of sepsis therapy.
Detailed Description
Sepsis is a common and devastating disease that is responsible for 215,000 deaths annually in the United States and is the leading cause of death in critically ill patients. Sepsis is now recognized a...
Eligibility Criteria
Inclusion
- Confirmed or suspected infection (acute)
- PLUS:
- One or both of the following criteria for potential tissue hypoperfusion:
- (2a) systolic blood pressure \<90 mmHg despite 30cc/kg intravenous crystalloid challenge, OR (2b) serum lactate \>4 mmol/L.
Exclusion
- age \< 14 years
- pregnancy
- "Do Not Resuscitate" status (prior to enrollment)
- active clinically significant bleeding of any etiology
- status-post cardiac arrest
- need for immediate surgery
- inability to place a sublingual videomicroscopy probe under the tongue (e.g. inability to open the mouth or patient requirement of a high-flow face mask for supplemental oxygen \[although videomicroscopy can be performed in patients with an endotracheal tube or nasal cannula\])
- \>24 hours elapsed since first documented evidence of meeting criteria for potential tissue hypoperfusion (2a or 2b above).
- inability to obtain written informed consent
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00608322
Start Date
August 1 2009
End Date
April 1 2013
Last Update
July 11 2013
Active Locations (1)
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1
Cooper University Hospital
Camden, New Jersey, United States, 08103