Trial Outcomes & Findings for Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease (NCT NCT04278625)
NCT ID: NCT04278625
Last Updated: 2024-04-29
Results Overview
The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration
Results posted on
2024-04-29
Participant Flow
Participant milestones
| Measure |
Cyanotic CHD
Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
Acyanotic CHD
Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
Baseline characteristics by cohort
| Measure |
Cyanotic CHD
n=15 Participants
Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
Acyanotic CHD
n=15 Participants
Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
3.6 years
n=5 Participants
|
3.58 years
n=7 Participants
|
3.59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Cardiopulmonary bypass time
|
78 minutes
n=5 Participants
|
73 minutes
n=7 Participants
|
73.5 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administrationThe amount of acetaminophen in the blood stream at each time point after receiving a standard dose.
Outcome measures
| Measure |
Cyanotic CHD
n=15 Participants
Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
Acyanotic CHD
n=15 Participants
Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Acetaminophen: IV acetaminophen given as part of standard of care.
|
|---|---|---|
|
Acetaminophen Serum Concentrations
6 Hours
|
2.5 mcg/mL
Interval 1.8 to 3.3
|
1.7 mcg/mL
Interval 1.4 to 2.9
|
|
Acetaminophen Serum Concentrations
15-20 minutes
|
19 mcg/mL
Interval 16.0 to 24.0
|
17 mcg/mL
Interval 15.0 to 19.0
|
|
Acetaminophen Serum Concentrations
30-40 minutes
|
13 mcg/mL
Interval 12.0 to 15.0
|
13 mcg/mL
Interval 12.0 to 14.0
|
|
Acetaminophen Serum Concentrations
50-70 minutes
|
11 mcg/mL
Interval 9.6 to 11.0
|
10 mcg/mL
Interval 9.2 to 11.0
|
|
Acetaminophen Serum Concentrations
80-100 minutes
|
8.7 mcg/mL
Interval 8.3 to 9.5
|
8 mcg/mL
Interval 6.9 to 9.1
|
|
Acetaminophen Serum Concentrations
2 Hours
|
6.9 mcg/mL
Interval 6.3 to 7.4
|
6.6 mcg/mL
Interval 5.3 to 8.4
|
|
Acetaminophen Serum Concentrations
4 Hours
|
4.1 mcg/mL
Interval 3.3 to 4.7
|
2.9 mcg/mL
Interval 2.7 to 4.4
|
Adverse Events
Cyanotic CHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acyanotic CHD
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