Trial Outcomes & Findings for Nitric Oxide Administration for Acute Respiratory Distress Syndrome (NCT NCT00240487)

Last Updated: 2015-04-24

Results Overview

Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

8 hours

Results posted on

2015-04-24

Participant Flow

Patients were recruited from the Pediatric Intensive Care Unit from 2000-2008.

Participant milestones

Participant milestones
Measure	Nitric Oxide First Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.	Delayed Nitric Oxide Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
Overall Study STARTED	24	28
Overall Study COMPLETED	24	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitric Oxide First n=24 Participants Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.	Delayed Nitric Oxide n=28 Participants Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.93 years STANDARD_DEVIATION 6.79 • n=5 Participants	8.06 years STANDARD_DEVIATION 6.28 • n=7 Participants	8.84 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	28 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Outcome measures

Outcome measures
Measure	Immediate Nitric Oxide Treatment n=24 Participants Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.	Delayed Nitric Oxide Treatment n=28 Participants Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
Mean PaO2/FiO2 Ratio	115.6 mmHg Standard Deviation 40.6	115.9 mmHg Standard Deviation 40

Adverse Events

Immediate Treatment With Nitric Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Treatment With Nitric Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Lin

The Children's Hospital of Philadelphia

Phone: 2155905505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place