Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
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|ClinicalTrials.gov Identifier: NCT00608322|
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : July 11, 2013
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Inhaled nitric oxide Other: Sham inhaled nitric oxide||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Double-blind Placebo-controlled Trial of Inhaled Nitric Oxide for the Treatment of Microcirculatory Dysfunction and Organ Failure in Sepsis|
|Study Start Date :||August 2009|
|Primary Completion Date :||April 2013|
|Study Completion Date :||April 2013|
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Drug: Inhaled nitric oxide
Inhaled nitric oxide, 40 parts per million, for six hours.
Other Name: INOmax
Sham Comparator: 2
Subjects receive sham inhaled nitric oxide for six hours.
Other: Sham inhaled nitric oxide
Sham inhaled nitric oxide administration, 0 parts per million, for six hours.
- Change in the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 0-24 hours from protocol initiation ]
- Change in Sublingual Microcirculatory Flow Index (MFI) [ Time Frame: 0-2 hours of study drug administration ]The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.
- Lactate Clearance (Blood) [ Time Frame: 0-2 hours of study drug administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608322
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Stephen Trzeciak, MD, MPH||UMDNJ-Robert Wood Johnson Medical School at Camden, Cooper University Hospital, Camden, New Jersey|