Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique

Phase 4

Completed

• Conditions: Myocardial Protection in TOF Repair

• Registration Number: NCT02646254
• Lead Sponsor: SUNDER LAL NEGI

Brief Summary

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Detailed Description

Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-31
• Last Update Submitted: 2015-12-31
• Study First Posted: 2016-01-05
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Tetralogy of fallot

Exclusion Criteria

• TOF with absent pulmonary valve , TOF with pulmonary atresia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
resumption of spontaneous rhythm after aortic cross clamp off	10 minutes
inotropic score	First 24 hours
Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours	72hrs

Secondary Outcome Measures

Name	Time	Method
hospital mortality	30 days
duration of mechanical ventilation in hours	48 hours
echocardiographic assessment	6 months
ICU stay	7 days