Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

• Sponsor: Peter Winch (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04278625
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 20.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Drug: Acetaminophen

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
• Actual Study Start Date: Mar 23, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cyanotic CHD Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.	Drug: Acetaminophen; IV acetaminophen given as part of standard of care.
Acyanotic CHD Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.	Drug: Acetaminophen; IV acetaminophen given as part of standard of care.

Outcome Measures

Primary Outcome Measures

1. Change in 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]

   To determine the change in serum concentration of acetaminophen between each timepoint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Peter Winch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Winch, Associate Professor of Anesthesiology, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04278625
• Other Study ID Numbers: STUDY00000766
• First Posted: Feb 20, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Acetaminophen

Study Results

No Results Posted as of Apr 12, 2022