NCT03595111

Brief Summary

Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Status
unknown

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

Study Start

First participant enrolled

July 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 12, 2018

Last Update Submit

July 20, 2018

Conditions

Myocardial Protection

Keywords

Cardiac ProtectionPediatricMyocardial biopsyCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • Myocardial biopsy

    Myocardial cell edema either focal or diffuse was detected in histopathological examination

    within 24 hours

Secondary Outcomes (4)

  • The inotropic score

    within one month

  • Serum cardiac troponin level

    first 24 hours

  • 30-day mortality

    30 days

  • Type of cardiac rhythm on return

    within 24 hours

Study Arms (1)

Myocardial biopsy

EXPERIMENTAL

The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.

Procedure: myocardial biopsy

Interventions

myocardial biopsyPROCEDURE

Myocardial cell edema either focal or diffuse was detected in histopathological examination

Myocardial biopsy

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.
  • Hemodynamic stability.

You may not qualify if:

  • Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profossor of Anesthesiology

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 23, 2018

Study Start

July 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share