Trial Outcomes & Findings for Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement (NCT NCT01717209)
NCT ID: NCT01717209
Last Updated: 2017-10-09
Results Overview
Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.
COMPLETED
PHASE4
14 participants
8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
2017-10-09
Participant Flow
Participant milestones
| Measure |
Combined Nitric Oxide and Prostacyclin
Inhaled nitric oxide (iNO; 20 ppm continuously) and inhaled prostacyclin (iPGI2; 0.05 micrograms/kg/min continuously)
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Baseline characteristics by cohort
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Age, Continuous
|
57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Pulmonary Hypertension
Following iNO+iPGI2 (1st)
|
25.9 mmHg
Interval 17.0 to 36.0
|
|
Pulmonary Hypertension
Following iPGI2
|
25.4 mmHg
Interval 15.0 to 38.0
|
|
Pulmonary Hypertension
Following iNO+iPGI2 (2nd)
|
25.4 mmHg
Interval 12.0 to 46.0
|
|
Pulmonary Hypertension
At Arrival in ICU
|
31.4 mmHg
Interval 20.0 to 43.0
|
|
Pulmonary Hypertension
Following iNO
|
29.1 mmHg
Interval 16.0 to 44.0
|
SECONDARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Right Heart Dysfunction was measured as mean of Right Ventricular Stroke Work Index (RVSWI) for the initial 8 hours after admission to the Intensive Care Unit (ICU). RVSWI is measured as the difference in mean pulmonary artery pressure (MPAP) and central venous pressure (CVP), divided by the cardiac index (CI): \[(MPAP-CVP) / CI\]. Normal range for RVSWI is 5-10 g/m.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Right Heart Dysfunction
At Arrival in ICU
|
5.2 g/m
Interval 2.64 to 11.15
|
|
Right Heart Dysfunction
Following iNO
|
5.0 g/m
Interval 1.45 to 9.06
|
|
Right Heart Dysfunction
Following iNO+iPGI2 (1st)
|
4.8 g/m
Interval 1.96 to 8.4
|
|
Right Heart Dysfunction
Following iPGI2
|
5.4 g/m
Interval 2.1 to 13.14
|
|
Right Heart Dysfunction
Following iNO+iPGI2 (2nd)
|
4.9 g/m
Interval 1.3 to 10.05
|
SECONDARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Systemic Vascular Resistance (SVR) was measured as mean of Systemic Vascular Resistance (SVR) for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for SVR is 800-1200 dynes/sec/cm5.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Systemic Vascular Resistance (SVR)
At Arrival in ICU
|
1193.9 dynes/sec/cm^5
Interval 488.0 to 1542.0
|
|
Systemic Vascular Resistance (SVR)
Following iNO
|
1169.7 dynes/sec/cm^5
Interval 898.0 to 1945.0
|
|
Systemic Vascular Resistance (SVR)
Following iNO+iPGI2 (2nd)
|
1145.9 dynes/sec/cm^5
Interval 783.0 to 1649.0
|
|
Systemic Vascular Resistance (SVR)
Following iNO+iPGI2 (1st)
|
1070.6 dynes/sec/cm^5
Interval 736.0 to 1520.0
|
|
Systemic Vascular Resistance (SVR)
Following iPGI2
|
1132.4 dynes/sec/cm^5
Interval 711.0 to 1640.0
|
SECONDARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Central Venous Pressure (CVP) was measured as mean of CVP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for CVP is 3-8 mmHg.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Central Venous Pressure (CVP)
At Arrival in ICU
|
12.7 mmHg
Interval 4.0 to 19.0
|
|
Central Venous Pressure (CVP)
Following iNO
|
12.6 mmHg
Interval 5.0 to 18.0
|
|
Central Venous Pressure (CVP)
Following iNO+iPGI2 (1st)
|
11.6 mmHg
Interval 6.0 to 15.0
|
|
Central Venous Pressure (CVP)
Following iPGI2
|
10.1 mmHg
Interval 2.0 to 15.0
|
|
Central Venous Pressure (CVP)
Following iNO+iPGI2 (2nd)
|
10.6 mmHg
Interval 4.0 to 14.0
|
SECONDARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Mean Arterial Pressure (MAP) was measured as mean of MAP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for MAP is 70-110 mmHg.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Mean Arterial Pressure (MAP)
At Arrival in ICU
|
86.29 mmHg
Interval 68.0 to 102.0
|
|
Mean Arterial Pressure (MAP)
Following iNO
|
80.86 mmHg
Interval 62.0 to 91.0
|
|
Mean Arterial Pressure (MAP)
Following iNO+iPGI2 (1st)
|
79.00 mmHg
Interval 67.0 to 89.0
|
|
Mean Arterial Pressure (MAP)
Following iPGI2
|
79.43 mmHg
Interval 63.0 to 91.0
|
|
Mean Arterial Pressure (MAP)
Following iNO+iPGI2 (2nd)
|
80.86 mmHg
Interval 61.0 to 103.0
|
SECONDARY outcome
Timeframe: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))Heart Rate was measured as mean of Heart Rate for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for heart rate is generally 60 to 100 beats per minutes in adults, but this can vary.
Outcome measures
| Measure |
Combined Nitric Oxide and Prostacyclin
n=14 Participants
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
|
|---|---|
|
Heart Rate
At Arrival in ICU
|
111.1 beats/minute
Interval 75.0 to 152.0
|
|
Heart Rate
Following iNO
|
112.5 beats/minute
Interval 71.0 to 166.0
|
|
Heart Rate
Following iNO+iPGI2 (1st)
|
108.4 beats/minute
Interval 73.0 to 161.0
|
|
Heart Rate
Following iPGI2
|
106.0 beats/minute
Interval 67.0 to 134.0
|
|
Heart Rate
Following iNO+iPGI2 (2nd)
|
104.6 beats/minute
Interval 73.0 to 119.0
|
Adverse Events
Combined Nitric Oxide and Prostacyclin
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