Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Not Applicable

Terminated

• Conditions: Cardiac Dysfunction
• Interventions: Diagnostic Test: Echocardiogram

• Registration Number: NCT03085420
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

Detailed Description

The investigators hope to learn the following:

* If heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury.

* The difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia.

* A better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.

Study Timeline

• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-05-03
• Primary Completion: 2018-10-21
• Study Completion: 2018-10-21
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Pediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study.

Group 1 will consist of patients with ≥30% TBSA burn injury. Group 2 will consist of patients with <30% TBSA burn injury who develop a cardiac abnormality.

Exclusion Criteria

Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
≥30% TBSA burn injury	Echocardiogram	For patients in Group 1 with ≥30% TBSA, a baseline Echocardiogram (ECHO) will be obtained approximately one week from admission and monthly (+/- 1 week) or at an interval determined by cardiology during the acute inpatient stay. ECHO tests will be discontinued after 3 negative exams or when discontinued by cardiology, whichever comes first.

Primary Outcome Measures

Name	Time	Method
Frequency of cardiac dysfunction in pediatric burn patients	Through study completion up to 4 years after hospital discharge.	Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.

Secondary Outcome Measures

Name	Time	Method
Acute care hospital length of stay	Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).	Hospital length of stay (admission date to discharge date) will be compared between participants with cardiac dysfunction versus participants without cardiac dysfunction.

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Cincinnati, Ohio, United States