Clinical Trials Directory

Trials / Completed

CompletedNCT03229980

Pediatric Myocardial Protection With Potassium Cardioplegia

Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
87 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Not accepted

Summary

The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation

Detailed description

After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups

Conditions

Interventions

TypeNameDescription
DRUGCold blood cardioplegia (large volume)Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg
DRUGCold blood cardioplegia (small volume)Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg

Timeline

Start date
2017-08-10
Primary completion
2018-04-03
Completion
2018-04-28
First posted
2017-07-26
Last updated
2018-05-15

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03229980. Inclusion in this directory is not an endorsement.