Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

NCT ID: NCT03085420

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2018-10-21

Brief Summary

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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

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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.

Conditions

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Cardiac Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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≥30% TBSA burn injury

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.

Group Type EXPERIMENTAL

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.

<30% TBSA burn injury

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Echocardiogram

A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ECHO

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Ivan Wilmot

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Wilmot, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Petra M Warner, MD

Role: STUDY_DIRECTOR

Shriners Hospitals for Children

Locations

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Shriners Hospitals for Children

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16819352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23237822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26729111 (View on PubMed)

Other Identifiers

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CIN1604

Identifier Type: -

Identifier Source: org_study_id

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