Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

November 15, 2023 updated by: Peter Winch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetaminophen Serum Concentrations
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Winch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2021

Primary Completion (Actual)

February 16, 2022

Study Completion (Actual)

February 16, 2022

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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