Congenital Heart DiseaseNCT04278625

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

An observational study of Congenital Heart Disease, run by Peter Winch at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Congenital Heart Disease
What is being tested?: Acetaminophen
Type of treatment: Injection or infusion
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2021to 16 Feb 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

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
Being tested: Acetaminophen
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetaminophenDrug
IV acetaminophen given as part of standard of care.

Study groups in NCT04278625
Study group	Role	What they receive
Cyanotic CHD		Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. Receives: Drug: Acetaminophen
Acyanotic CHD		Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy. Receives: Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

Acetaminophen Serum Concentrations
The amount of acetaminophen in the blood stream at each time point after receiving a standard dose.
Measured: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202116 Feb 2022

First posted20 Feb 2020
Study start23 Mar 2021
Primary completion16 Feb 2022
Study completion16 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04278625
Sponsor's protocol ID: STUDY00000766
Status last verified: Nov 2023
First submitted: 10 Feb 2020
Last updated: 29 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation

All Congenital Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
ClinicalTrials.gov ID: NCT04278625
Acronym / sponsor ID: STUDY00000766
Conditions: Congenital Heart Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Peter WinchUniversity, hospital or other
Study start: 23 Mar 2021 (actual)
Primary completion: 16 Feb 2022 (actual)
Study completion: 16 Feb 2022 (actual)
First posted: 20 Feb 2020 (actual)
Results: Posted 29 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cyanotic CHD	–	Drug: AcetaminophenCyanotic congenital heart disease (CHD) patients presenting for Fontan palliation.
Acyanotic CHD	–	Drug: AcetaminophenAcyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Pediatric congenital heard disease patients undergoing cardiac surgery and receiving IV acetaminophen during their surgical procedure as standard of care.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcetaminophenIV acetaminophen given as part of standard of care.	Drug	Acyanotic CHD, Cyanotic CHD

Primary outcome

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.

Results and safety

Results posted to the registry on 29 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cyanotic CHD	15	15
Acyanotic CHD	15	15

Primary outcome: 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. Median (Inter-Quartile Range). Unit: mcg/mL

Measure	Cyanotic CHD n = 15	Acyanotic CHD n = 15
15-20 minutes	19 (16 to 24)	17 (15 to 19)
30-40 minutes	13 (12 to 15)	13 (12 to 14)
50-70 minutes	11 (9.6 to 11)	10 (9.2 to 11)
80-100 minutes	8.7 (8.3 to 9.5)	8 (6.9 to 9.1)
2 Hours	6.9 (6.3 to 7.4)	6.6 (5.3 to 8.4)
4 Hours	4.1 (3.3 to 4.7)	2.9 (2.7 to 4.4)
6 Hours	2.5 (1.8 to 3.3)	1.7 (1.4 to 2.9)

Adverse events

Time frame: 1 week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cyanotic CHD	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Acyanotic CHD	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Congenital Heart Disease

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by Peter Winch at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.