NCT03085420

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

January 19, 2017

Last Update Submit

November 5, 2018

Conditions

Cardiac Dysfunction

Keywords

BurnsPediatricsCardiac Arrhythmia

Outcome Measures

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.

    Through study completion up to 4 years after hospital discharge.

Secondary Outcomes (1)

  • 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).

Study Arms (2)

≥30% TBSA burn injury

EXPERIMENTAL

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

<30% TBSA burn injury

NO INTERVENTION

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

EchocardiogramDIAGNOSTIC_TEST

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
≥30% TBSA burn injury

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

  • 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.

    PMID: 16819352BACKGROUND

  • 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.

    PMID: 23237822BACKGROUND

  • 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.

    PMID: 26729111BACKGROUND

MeSH Terms

Conditions

BurnsArrhythmias, Cardiac

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Wounds and InjuriesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Ivan Wilmot, MD

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

  • Petra M Warner, MD

    Shriners Hospitals for Children

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2017

First Posted

March 21, 2017

Study Start

May 3, 2017

Primary Completion

October 21, 2018

Study Completion

October 21, 2018

Last Updated

November 7, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)