Trial Outcomes & Findings for Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass (NCT NCT00585013)
NCT ID: NCT00585013
Last Updated: 2015-11-04
Results Overview
Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
48 hours
Results posted on
2015-11-04
Participant Flow
Patients were randomized by the research perfusionist using sequentially ordered randomization codes. The randomization codes were generated using a computerized random number generator. The entire care team was blinded to the delivery device and drug delivery. Only the study perfusionist was aware of randomization and delivery.
Seventeen patients consented and were enrolled in the study. There were eight consent failures. One patient was disqualified after consent and randomization due to intraoperative findings of a lesion inconsistent with preoperative diagnosis and change in operative plan.
Participant milestones
| Measure |
1 Treatment
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
2 Placebo
Placebo delivery of oxygen at standard dose.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Baseline characteristics by cohort
| Measure |
1 Treatment
n=8 Participants
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
2 Placebo
n=8 Participants
Placebo delivery of oxygen at standard dose.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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
|
.4 years
STANDARD_DEVIATION .1 • n=5 Participants
|
.4 years
STANDARD_DEVIATION .1 • n=7 Participants
|
.4 years
STANDARD_DEVIATION .1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursInflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.
Outcome measures
| Measure |
Nitric Oxide Delivery Group
n=8 Participants
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
Placebo
n=8 Participants
Placebo delivery of oxygen at standard dose.
|
|---|---|---|
|
Serum Inflammatory Mediators Post CPB
Interleukin-6 Preoperative
|
3.8 ng/mL
Standard Deviation 3.5
|
3.4 ng/mL
Standard Deviation 2.5
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-6, 0 hrs
|
90.9 ng/mL
Standard Deviation 44.6
|
78.3 ng/mL
Standard Deviation 45.7
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-6, 12 hrs
|
51.5 ng/mL
Standard Deviation 38.7
|
73.3 ng/mL
Standard Deviation 67.0
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-6, 24 hrs
|
64.2 ng/mL
Standard Deviation 28.4
|
80.7 ng/mL
Standard Deviation 82.1
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-6, 48 hrs
|
31.2 ng/mL
Standard Deviation 30.6
|
39.4 ng/mL
Standard Deviation 48.9
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-8, Preoperative
|
60.9 ng/mL
Standard Deviation 28.8
|
39.8 ng/mL
Standard Deviation 39.0
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-8, 0 hrs
|
189.8 ng/mL
Standard Deviation 104.1
|
248.9 ng/mL
Standard Deviation 191.7
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-8, 12 hrs
|
144 ng/mL
Standard Deviation 133.4
|
85.9 ng/mL
Standard Deviation 59.9
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-8, 24 hrs
|
101.5 ng/mL
Standard Deviation 62.7
|
139.2 ng/mL
Standard Deviation 162.1
|
|
Serum Inflammatory Mediators Post CPB
Interleukin-8, 48 hrs
|
134.2 ng/mL
Standard Deviation 107.0
|
60.4 ng/mL
Standard Deviation 33.7
|
|
Serum Inflammatory Mediators Post CPB
Tumor Necrosis Factor Preoperative
|
2.9 ng/mL
Standard Deviation 0.8
|
3.2 ng/mL
Standard Deviation 1.1
|
|
Serum Inflammatory Mediators Post CPB
Tumor Necrosis Factor, 0 hrs
|
3.2 ng/mL
Standard Deviation 1.5
|
4.1 ng/mL
Standard Deviation 1.6
|
|
Serum Inflammatory Mediators Post CPB
Tumor Necrosis Factor, 12 hrs
|
1.7 ng/mL
Standard Deviation 0.07
|
1.9 ng/mL
Standard Deviation 1.1
|
|
Serum Inflammatory Mediators Post CPB
Tumor Necrosis Factor, 24 hrs
|
1.7 ng/mL
Standard Deviation 1.3
|
3.2 ng/mL
Standard Deviation 2.9
|
|
Serum Inflammatory Mediators Post CPB
Tumor Necrosis Factor, 48 hrs
|
2.8 ng/mL
Standard Deviation 0.09
|
2.1 ng/mL
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 48 hoursTroponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury
Outcome measures
| Measure |
Nitric Oxide Delivery Group
n=8 Participants
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
Placebo
n=8 Participants
Placebo delivery of oxygen at standard dose.
|
|---|---|---|
|
Myocardial Injury
Preoperative
|
0.07 ng/mL
Standard Deviation 0.07
|
0.06 ng/mL
Standard Deviation 0.1
|
|
Myocardial Injury
0 h
|
50.6 ng/mL
Standard Deviation 37.8
|
54.1 ng/mL
Standard Deviation 15.5
|
|
Myocardial Injury
12 h
|
11.7 ng/mL
Standard Deviation 3.2
|
15.9 ng/mL
Standard Deviation 3.5
|
|
Myocardial Injury
24 h
|
8.9 ng/mL
Standard Deviation 2.6
|
12.5 ng/mL
Standard Deviation 2.7
|
|
Myocardial Injury
48 h
|
4.8 ng/mL
Standard Deviation 1.6
|
7.6 ng/mL
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 48 hoursBNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function.
Outcome measures
| Measure |
Nitric Oxide Delivery Group
n=8 Participants
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
Placebo
n=8 Participants
Placebo delivery of oxygen at standard dose.
|
|---|---|---|
|
Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels
Preoperative
|
24 pg/dL
Standard Deviation 22
|
100 pg/dL
Standard Deviation 195
|
|
Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels
0 h
|
43 pg/dL
Standard Deviation 34
|
94 pg/dL
Standard Deviation 100
|
|
Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels
12 h
|
494 pg/dL
Standard Deviation 222
|
812 pg/dL
Standard Deviation 300
|
|
Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels
24 h
|
425 pg/dL
Standard Deviation 154
|
938 pg/dL
Standard Deviation 511
|
|
Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels
48 h
|
558 pg/dL
Standard Deviation 535
|
1298 pg/dL
Standard Deviation 827
|
PRIMARY outcome
Timeframe: 48 hoursLactate levels correlate to ischemic injury. Higher values represent more injury.
Outcome measures
| Measure |
Nitric Oxide Delivery Group
n=8 Participants
Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.
|
Placebo
n=8 Participants
Placebo delivery of oxygen at standard dose.
|
|---|---|---|
|
Ischemic Injury as Measured by Lactate Levels
Preoperative
|
0.9 mmol/L
Standard Deviation 0.2
|
0.5 mmol/L
Standard Deviation 0.1
|
|
Ischemic Injury as Measured by Lactate Levels
0 h
|
1.9 mmol/L
Standard Deviation 0.6
|
1.9 mmol/L
Standard Deviation 1.0
|
|
Ischemic Injury as Measured by Lactate Levels
12 h
|
1.5 mmol/L
Standard Deviation 0.4
|
1.5 mmol/L
Standard Deviation 0.5
|
|
Ischemic Injury as Measured by Lactate Levels
24 h
|
1.4 mmol/L
Standard Deviation 0.5
|
1.4 mmol/L
Standard Deviation 0.4
|
|
Ischemic Injury as Measured by Lactate Levels
48 h
|
1.1 mmol/L
Standard Deviation 0.2
|
1.1 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data not collected for these assessments
Outcome measures
Outcome data not reported
Adverse Events
1 Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place