Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
|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 ]
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|