Trial Outcomes & Findings for Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation (NCT NCT02498444)
NCT ID: NCT02498444
Last Updated: 2022-03-31
Results Overview
This outcome measures the number of days that chest tubes were in place postoperatively.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
2-3 wks
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
Treprostinil
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Treprostinil
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
Baseline characteristics by cohort
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=18 Participants
Saline administration via subcutaneous infusion.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Congenital Heart Disease
Double outlet right ventricle
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Congenital Heart Disease
Pulmonary atresia with intact ventricular septum
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
4.09 years
n=99 Participants
|
4.51 years
n=107 Participants
|
4.16 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ventricular morphology
Left ventricle
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ventricular morphology
Right ventricle
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Congenital Heart Disease
Hypoplastic left heart syndrome
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Congenital Heart Disease
Double inlet left ventricle
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Congenital Heart Disease
Tricuspid atresia
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Congenital Heart Disease
Atrioventricular septal defect
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Congenital Heart Disease
L-transposition of the great arteries + pulmonary atresia
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Baseline ventricular function
Normal function
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Baseline ventricular function
Mildly depressed function
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Systemic atrioventricular valve function
No regurgitation
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Systemic atrioventricular valve function
Trace regurgitation
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Systemic atrioventricular valve function
Mild regurgitation
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Systemic atrioventricular valve function
Mild-Moderate regurgitation
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Systemic atrioventricular valve function
Moderate regurgitation
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Baseline Pulmonary Arterial Pressure
|
11.0 mmHg
n=99 Participants
|
9.0 mmHg
n=107 Participants
|
10.0 mmHg
n=206 Participants
|
|
Baseline Atrial Pressure
|
7.0 mmHg
n=99 Participants
|
5.0 mmHg
n=107 Participants
|
5.0 mmHg
n=206 Participants
|
|
Baseline Transpulmonary Gradient
|
4.0 mmHg
n=99 Participants
|
4.0 mmHg
n=107 Participants
|
4.0 mmHg
n=206 Participants
|
|
Baseline Pulmonary Vascular Resistance
|
1.12 indexed Wood units (WU*m^2)
n=99 Participants
|
1.25 indexed Wood units (WU*m^2)
n=107 Participants
|
1.2 indexed Wood units (WU*m^2)
n=206 Participants
|
PRIMARY outcome
Timeframe: 2-3 wksPopulation: Intention to treat analysis based on study group assignment at randomization.
This outcome measures the number of days that chest tubes were in place postoperatively.
Outcome measures
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=18 Participants
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Chest Tube Duration
|
8.0 days
Interval 7.0 to 12.5
|
7.0 days
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: 2-3 wksPopulation: Intention to treat analysis based on group assignment at randomization
This outcome measures the hospital length of stays in days.
Outcome measures
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=18 Participants
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Length of Hospital Stay
|
11.0 days
Interval 9.5 to 14.5
|
9.0 days
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: postoperative hour 0, 12 and 24Population: Participants with available data at the respective time points are included in the analysis.
Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups
Outcome measures
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=18 Participants
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Postoperative Fontan Pressure
Fontan pressure- postoperative hour 0
|
13.0 mmHg
Interval 11.0 to 15.0
|
12.5 mmHg
Interval 11.0 to 13.25
|
|
Postoperative Fontan Pressure
Fontan pressure- postoperative hour 12
|
13.0 mmHg
Interval 12.25 to 15.0
|
10.5 mmHg
Interval 8.0 to 12.75
|
|
Postoperative Fontan Pressure
Fontan pressure- postoperative hour 24
|
13.0 mmHg
Interval 11.5 to 15.5
|
9.0 mmHg
Interval 8.0 to 15.5
|
SECONDARY outcome
Timeframe: postoperative hour 0, 12 and 24Population: Participants with available data at the respective time points are included in the analysis.
Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups
Outcome measures
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=17 Participants
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Postoperative Atrial Pressure
Postoperative hour 12
|
6.0 mmHg
Interval 5.0 to 8.75
|
6.0 mmHg
Interval 4.0 to 8.0
|
|
Postoperative Atrial Pressure
Postoperative hour 0
|
7.0 mmHg
Interval 5.0 to 9.0
|
5.0 mmHg
Interval 4.0 to 7.0
|
|
Postoperative Atrial Pressure
Postoperative hour 24
|
6.0 mmHg
Interval 5.0 to 12.0
|
7.0 mmHg
Interval 4.25 to 10.75
|
SECONDARY outcome
Timeframe: postoperative hour 0, 12 and 24Population: Participants with available data at the respective time points are included in the analysis.
Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups. Transpulmonary pressure gradient is defined as the difference between mean pulmonary artery pressure and left atrial pressure (commonly estimated by a pulmonary artery wedge pressure).
Outcome measures
| Measure |
Treprostinil
n=16 Participants
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=17 Participants
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
Postoperative Transpulmonary Gradient
Postoperative hour 0
|
7.0 mmHg
Interval 5.0 to 8.0
|
7.0 mmHg
Interval 5.0 to 7.5
|
|
Postoperative Transpulmonary Gradient
Postoperative hour 12
|
7.0 mmHg
Interval 5.0 to 9.75
|
4.0 mmHg
Interval 3.25 to 5.0
|
|
Postoperative Transpulmonary Gradient
Postoperative hour 24
|
6.0 mmHg
Interval 5.0 to 10.0
|
6.0 mmHg
Interval 4.0 to 7.0
|
Adverse Events
Treprostinil
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treprostinil
n=16 participants at risk
Subcutaneous continuous treprostinil infusion starting at 2 ng/kg/min, increased over the first 24 hours to goal 10 ng/kg/min through day five, then decreased by 2 ng/kg/min every 8 hours starting on postoperative day six with plans for discontinuation on postoperative day seven.
|
Saline
n=18 participants at risk
Saline administration via subcutaneous infusion.
|
|---|---|---|
|
General disorders
Site pain
|
43.8%
7/16 • Adverse event data were collected during hospitalization, which was generally between 1-3 weeks.
|
0.00%
0/18 • Adverse event data were collected during hospitalization, which was generally between 1-3 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place