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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 15 • n=5 Participants	58 years STANDARD_DEVIATION 20 • n=7 Participants	58 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	23 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-24 hours from protocol initiation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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 administration

Outcome 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

Stephen Trzeciak, MD, MPH

Cooper University Hospital

Phone: 856-342-3342

Email: trzeciak-stephen@cooperhealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place