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TerminatedNCT03085420Updated Nov 7, 2018

Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

An interventional study of Echocardiogram in Cardiac Dysfunction, sponsored by Shriners Hospitals for Children. Terminated at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by Shriners Hospitals for Children · Not applicable, Interventional, and Other

Why this study was terminated
Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
Up to 18 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Cardiac Dysfunction

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Keywords

  • Burns
  • Pediatrics
  • Cardiac Arrhythmia
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 10 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Shriners Hospitals for Children is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    ≥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.

    Diagnostic Test: Echocardiogram

  • No intervention
    <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.

Interventions

  • Diagnostic testEchocardiogram

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

    Also known as: ECHO

06

What researchers measure

Primary outcomes

  1. Frequency of cardiac dysfunction in pediatric burn patients

    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 outcomes

  1. 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.

    Time frame: Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).

07

Study locations

1 site
  • Shriners Hospitals for Children
    Cincinnati, Ohio 45229, United States
08

References and documents

Publications

  • 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. PubMed 16819352 ↗
  • 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. PubMed 23237822 ↗
  • 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. PubMed 26729111 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03085420
Lead sponsor
Shriners Hospitals for Children
Responsible party
Ivan Wilmot (Principal Investigator, Shriners Hospitals for Children) — Principal investigator
First posted
Mar 21, 2017
Start date
May 3, 2017
Primary completion
Oct 21, 2018
Completion
Oct 21, 2018
Last update
Nov 7, 2018

Study contacts

Ivan Wilmot, MD
principal investigator · Shriners Hospitals for Children
Petra M Warner, MD
study director · Shriners Hospitals for Children

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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