Cardiac DysfunctionNCT03085420
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
A study testing Echocardiogram in people with Cardiac Dysfunction, run by Shriners Hospitals for Children at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Dysfunction
- What is being tested?
- Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 21 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Cincinnati, Ohio, 45229
About this study
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.
- Conditions
- Cardiac Dysfunction
- Being tested
- Echocardiogram
- Keywords
- Burns, Pediatrics, Cardiac Arrhythmia
- Medical subject headings
- Burns, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Also called ECHO
A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.
| Study group | Role | What they receive |
|---|---|---|
| ≥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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cardiac dysfunction in pediatric burn patients
Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.
Measured: 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.
Measured: Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start3 May 2017
- Primary completion21 Oct 2018
- Study completion21 Oct 2018
Why it stopped: Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Wilmot, Shriners Hospitals for Children
- Investigators
- Ivan Wilmot, MD, Principal investigator, Shriners Hospitals for ChildrenPetra M Warner, MD, Study director, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085420
- Sponsor's protocol ID
- CIN1604
- Status last verified
- Nov 2018
- First submitted
- 19 Jan 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16819352Howard 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 23237822Guillory 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
- ClinicalTrials.gov ID
- NCT03085420
- Acronym / sponsor ID
- CIN1604
- Conditions
- Cardiac Dysfunction
- Keywords
- Burns, Pediatrics, Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 21 Oct 2018 (actual)
- Study completion
- 21 Oct 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ≥30% TBSA burn injury | Experimental | Diagnostic Test: EchocardiogramFor 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. |
| <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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramAlso: ECHOA baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist. | Diagnostic test | ≥30% TBSA burn injury |
Primary outcome
Frequency of cardiac dysfunction in pediatric burn patients
Time frame: Through study completion up to 4 years after hospital discharge.
Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction.
1 secondary outcome
Acute care hospital length of stay
Time frame: Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).
Results and safety
The study was stopped early (reason given: Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 16819352Mak 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.
- Background: PubMed 23237822Howard 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.
- Background: PubMed 26729111Guillory 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Wilmot, MD principal investigator
Shriners Hospitals for Children
Petra M Warner, MD study director
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiogram in people with Cardiac Dysfunction, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participating site withdrew prior to any enrollment and lead site with slow enrollment. Not expected to meet enrollment goals.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of cardiac dysfunction in pediatric burn patients (time frame: Through study completion up to 4 years after hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.