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

SUNDER LAL NEGI56 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Myocardial Protection in TOF Repair

Interventions

blood cardioplegiaOTHER

del nido cardioplegiaOTHER

Eligibility

Sex: ALLMin age: 1 YearMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Tetralogy of fallot Exclusion Criteria: * TOF with absent pulmonary valve , TOF with pulmonary atresia

Outcomes

Primary Outcomes

inotropic score

Time frame: First 24 hours

Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours

Time frame: 72hrs

resumption of spontaneous rhythm after aortic cross clamp off

Time frame: 10 minutes

Secondary Outcomes

duration of mechanical ventilation in hours

Time frame: 48 hours

ICU stay

Time frame: 7 days

hospital mortality

Time frame: 30 days

echocardiographic assessment

Time frame: 6 months

Data from ClinicalTrials.gov

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