Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

NCT04278625 | Completed Results FDA Drug

• 1 other identifier: STUDY00000766
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Acetaminophen Serum Concentrations

  The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.

  15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration

Study Arms (2)

Cyanotic CHD

Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.

Drug: Acetaminophen

Acyanotic CHD

Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

IV acetaminophen given as part of standard of care.

Acyanotic CHD; Cyanotic CHD

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric congenital heard disease patients undergoing cardiac surgery and receiving IV acetaminophen during their surgical procedure as standard of care.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Winch: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Peter Winch
• Organization: Nationwide Children's Hospital

peter.winch@nationwidechildrens.org

614-722-5936

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 20, 2020
• Study Start: March 23, 2021
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)