Trial Outcomes & Findings for Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis (NCT NCT00608322)
NCT ID: NCT00608322
Last Updated: 2013-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
49 participants
Primary outcome timeframe
0-24 hours from protocol initiation
Results posted on
2013-07-11
Participant Flow
We enrolled septic patients in the Emergency Department and Intensive Care Unit
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide
n=26 Participants
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
|
Sham (Comparator)
n=23 Participants
Subjects receive sham inhaled nitric oxide for six hours.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 15 • n=99 Participants
|
58 years
STANDARD_DEVIATION 20 • n=107 Participants
|
58 years
STANDARD_DEVIATION 17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
23 participants
n=107 Participants
|
49 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-24 hours from protocol initiationOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0-2 hours of study drug administrationThe MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=24 Participants
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
|
Sham (Comparator)
n=22 Participants
Subjects receive sham inhaled nitric oxide for six hours.
|
|---|---|---|
|
Change in Sublingual Microcirculatory Flow Index (MFI)
|
-0.06 units on a scale
Interval -0.19 to 0.04
|
-0.03 units on a scale
Interval -0.13 to 0.17
|
SECONDARY outcome
Timeframe: 0-2 hours of study drug administrationOutcome measures
Outcome data not reported
Adverse Events
Inhaled Nitric Oxide
Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths
Sham (Comparator)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Nitric Oxide
n=26 participants at risk
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
|
Sham (Comparator)
n=23 participants at risk
Subjects receive sham inhaled nitric oxide for six hours.
|
|---|---|---|
|
General disorders
Death
|
34.6%
9/26 • Participants were followed for the duration of hospital stay, an average of 5 weeks.
|
26.1%
6/23 • Participants were followed for the duration of hospital stay, an average of 5 weeks.
|
Other adverse events
| Measure |
Inhaled Nitric Oxide
n=26 participants at risk
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
|
Sham (Comparator)
n=23 participants at risk
Subjects receive sham inhaled nitric oxide for six hours.
|
|---|---|---|
|
General disorders
Death
|
34.6%
9/26 • Participants were followed for the duration of hospital stay, an average of 5 weeks.
|
26.1%
6/23 • Participants were followed for the duration of hospital stay, an average of 5 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place