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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
Sponsor:
Information provided by (Responsible Party):
Dr. Trzeciak, The Cooper Health System

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sepsis
Interventions: Drug: Inhaled nitric oxide
Other: Sham inhaled nitric oxide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled septic patients in the Emergency Department and Intensive Care Unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Sham (Comparator) Subjects receive sham inhaled nitric oxide for six hours.

Participant Flow:   Overall Study
    Inhaled Nitric Oxide   Sham (Comparator)
STARTED   26   23 
COMPLETED   24   22 
NOT COMPLETED   2   1 
Death                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Sham (Comparator) Subjects receive sham inhaled nitric oxide for six hours.
Total Total of all reporting groups

Baseline Measures
   Inhaled Nitric Oxide   Sham (Comparator)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   23   49 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   14   31 
>=65 years   9   9   18 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (15)   58  (20)   58  (17) 
Gender 
[Units: Participants]
     
Female   15   10   25 
Male   11   13   24 
Region of Enrollment 
[Units: Participants]
     
United States   26   23   49 


  Outcome Measures

1.  Primary:   Change in Sublingual Microcirculatory Flow Index (MFI)   [ Time Frame: 0-2 hours of study drug administration ]

2.  Primary:   Change in the Sequential Organ Failure Assessment (SOFA) Score   [ Time Frame: 0-24 hours from protocol initiation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Lactate Clearance (Blood)   [ Time Frame: 0-2 hours of study drug administration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen Trzeciak, MD, MPH
Organization: Cooper University Hospital
phone: 856-342-3342
e-mail: trzeciak-stephen@cooperhealth.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Trzeciak, The Cooper Health System
ClinicalTrials.gov Identifier: NCT00608322     History of Changes
Other Study ID Numbers: K23GM083211 ( U.S. NIH Grant/Contract )
1K23GM083211-01 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: April 16, 2013
Results First Posted: July 11, 2013
Last Update Posted: July 11, 2013