Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Cardiac Dysfunction Clinical Trial

Official title:

Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03085420
• Other study ID #: CIN1604
• Status: Terminated
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: October 21, 2018

Study information

• Verified date: November 2018
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 21, 2018
• Est. primary completion date: October 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (3)

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). pii: E53. doi: 10.3390/ijms17010053. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).