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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
Enrollment 49
Recruitment Details We enrolled septic patients in the Emergency Department and Intensive Care Unit
Pre-assignment Details  
Arm/Group Title Inhaled Nitric Oxide Sham (Comparator)
Hide Arm/Group Description Subjects receive inhaled nitric oxide (40 parts per million) for six hours. Subjects receive sham inhaled nitric oxide for six hours.
Period Title: Overall Study
Started 26 23
Completed 24 22
Not Completed 2 1
Reason Not Completed
Death             2             1
Arm/Group Title Inhaled Nitric Oxide Sham (Comparator) Total
Hide Arm/Group Description Subjects receive inhaled nitric oxide (40 parts per million) for six hours. Subjects receive sham inhaled nitric oxide for six hours. Total of all reporting groups
Overall Number of Baseline Participants 26 23 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  65.4%
14
  60.9%
31
  63.3%
>=65 years
9
  34.6%
9
  39.1%
18
  36.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 49 participants
59  (15) 58  (20) 58  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
Female
15
  57.7%
10
  43.5%
25
  51.0%
Male
11
  42.3%
13
  56.5%
24
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 23 participants 49 participants
26 23 49
1.Primary Outcome
Title Change in the Sequential Organ Failure Assessment (SOFA) Score
Hide Description [Not Specified]
Time Frame 0-24 hours from protocol initiation
Outcome Measure Data Not Reported
2.Primary Outcome
Title Change in Sublingual Microcirculatory Flow Index (MFI)
Hide Description The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.
Time Frame 0-2 hours of study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Nitric Oxide Sham (Comparator)
Hide Arm/Group Description:
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Subjects receive sham inhaled nitric oxide for six hours.
Overall Number of Participants Analyzed 24 22
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-0.06
(-0.19 to 0.04)
-0.03
(-0.13 to 0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Nitric Oxide, Sham (Comparator)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lactate Clearance (Blood)
Hide Description [Not Specified]
Time Frame 0-2 hours of study drug administration
Outcome Measure Data Not Reported
Time Frame Participants were followed for the duration of hospital stay, an average of 5 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Nitric Oxide Sham (Comparator)
Hide Arm/Group Description Subjects receive inhaled nitric oxide (40 parts per million) for six hours. Subjects receive sham inhaled nitric oxide for six hours.
All-Cause Mortality
Inhaled Nitric Oxide Sham (Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Inhaled Nitric Oxide Sham (Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/26 (34.62%)   6/23 (26.09%) 
General disorders     
Death   9/26 (34.62%)  6/23 (26.09%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inhaled Nitric Oxide Sham (Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/26 (34.62%)   6/23 (26.09%) 
General disorders     
Death   9/26 (34.62%)  6/23 (26.09%) 
Indicates events were collected by systematic assessment
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
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