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Clinical Trials/NCT02646254
NCT02646254
Completed
Phase 4

MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES

SUNDER LAL NEGI0 sites56 target enrollmentJune 2014

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Myocardial Protection in TOF Repair
Sponsor
SUNDER LAL NEGI
Enrollment
56
Primary Endpoint
resumption of spontaneous rhythm after aortic cross clamp off
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
SUNDER LAL NEGI
Responsible Party
Sponsor Investigator
Principal Investigator

SUNDER LAL NEGI

Fellow, Cardiac anesthesia.

Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility Criteria

Inclusion Criteria

  • Tetralogy of fallot

Exclusion Criteria

  • TOF with absent pulmonary valve , TOF with pulmonary atresia

Outcomes

Primary Outcomes

resumption of spontaneous rhythm after aortic cross clamp off

Time Frame: 10 minutes

inotropic score

Time Frame: First 24 hours

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

Time Frame: 72hrs

Secondary Outcomes

  • hospital mortality(30 days)
  • duration of mechanical ventilation in hours(48 hours)
  • ICU stay(7 days)
  • echocardiographic assessment(6 months)

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