search
Back to results

Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Primary Purpose

Cardiac Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echocardiogram
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Dysfunction focused on measuring Burns, Pediatrics, Cardiac Arrhythmia

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shriners Hospitals for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

≥30% TBSA burn injury

<30% TBSA burn injury

Arm Description

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.

For patients in Group 2 with <30% TBSA and presence of a cardiac abnormality standard clinical care appropriate for the type of arrhythmia will be followed.

Outcomes

Primary Outcome Measures

Frequency of cardiac dysfunction in pediatric burn patients
Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.

Secondary Outcome Measures

Acute care hospital length of stay
Hospital length of stay (admission date to discharge date) will be compared between participants with cardiac dysfunction versus participants without cardiac dysfunction.

Full Information

First Posted
January 19, 2017
Last Updated
November 5, 2018
Sponsor
Shriners Hospitals for Children
search

1. Study Identification

Unique Protocol Identification Number
NCT03085420
Brief Title
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Official Title
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
October 21, 2018 (Actual)
Study Completion Date
October 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Dysfunction
Keywords
Burns, Pediatrics, Cardiac Arrhythmia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
≥30% TBSA burn injury
Arm Type
Experimental
Arm Description
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.
Arm Title
<30% TBSA burn injury
Arm Type
No Intervention
Arm Description
For patients in Group 2 with <30% TBSA and presence of a cardiac abnormality standard clinical care appropriate for the type of arrhythmia will be followed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiogram
Other Intervention Name(s)
ECHO
Intervention Description
A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.
Primary Outcome Measure Information:
Title
Frequency of cardiac dysfunction in pediatric burn patients
Description
Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.
Time Frame
Through study completion up to 4 years after hospital discharge.
Secondary Outcome Measure Information:
Title
Acute care hospital length of stay
Description
Hospital length of stay (admission date to discharge date) will be compared between participants with cardiac dysfunction versus participants without cardiac dysfunction.
Time Frame
Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Wilmot, MD
Organizational Affiliation
Shriners Hospitals for Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petra M Warner, MD
Organizational Affiliation
Shriners Hospitals for Children
Official's Role
Study Director
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16819352
Citation
Mak GZ, Hardy AR, Meyer RA, Kagan RJ. Reversible cardiomyopathy after severe burn injury. J Burn Care Res. 2006 Jul-Aug;27(4):482-6. doi: 10.1097/01.BCR.0000226018.30433.ED.
Results Reference
background
PubMed Identifier
23237822
Citation
Howard TS, Hermann DG, McQuitty AL, Woodson LC, Kramer GC, Herndon DN, Ford PM, Kinsky MP. Burn-induced cardiac dysfunction increases length of stay in pediatric burn patients. J Burn Care Res. 2013 Jul-Aug;34(4):413-9. doi: 10.1097/BCR.0b013e3182685e11.
Results Reference
background
PubMed Identifier
26729111
Citation
Guillory AN, Clayton RP, Herndon DN, Finnerty CC. Cardiovascular Dysfunction Following Burn Injury: What We Have Learned from Rat and Mouse Models. Int J Mol Sci. 2016 Jan 2;17(1):53. doi: 10.3390/ijms17010053.
Results Reference
background

Learn more about this trial

Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

We'll reach out to this number within 24 hrs