Congenital Heart Disease
Conditions
Brief summary
This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.
Interventions
DRUGAcetaminophen
IV acetaminophen given as part of standard of care.
Sponsors
Peter Winch
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study. * Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn.
Exclusion criteria
* Documentation of an allergy to acetaminophen * Severe hepatic disease or other contraindications to acetaminophen use * Patient has received acetaminophen within 24 hours of their procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen Serum Concentrations | 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration | The amount of acetaminophen in the blood stream at each time point after receiving a standard dose. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cyanotic CHD Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
Acetaminophen: IV acetaminophen given as part of standard of care. | 15 |
| Acyanotic CHD Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Acetaminophen: IV acetaminophen given as part of standard of care. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Cyanotic CHD | Acyanotic CHD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.6 years | 3.58 years | 3.59 years |
| Cardiopulmonary bypass time | 78 minutes | 73 minutes | 73.5 minutes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 12 Participants | 22 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Acetaminophen Serum Concentrations
The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.
Time frame: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cyanotic CHD | Acetaminophen Serum Concentrations | 50-70 minutes | 11 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 2 Hours | 6.9 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 30-40 minutes | 13 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 4 Hours | 4.1 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 80-100 minutes | 8.7 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 6 Hours | 2.5 mcg/mL |
| Cyanotic CHD | Acetaminophen Serum Concentrations | 15-20 minutes | 19 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 6 Hours | 1.7 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 15-20 minutes | 17 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 30-40 minutes | 13 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 50-70 minutes | 10 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 80-100 minutes | 8 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 2 Hours | 6.6 mcg/mL |
| Acyanotic CHD | Acetaminophen Serum Concentrations | 4 Hours | 2.9 mcg/mL |