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

NCT ID: NCT02646254

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myocardial Protection in TOF Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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blood cardioplegia

these patients received blood cardioplegia

Group Type ACTIVE_COMPARATOR

blood cardioplegia

Intervention Type OTHER

del nido cardioplegia

these patients received del nido cardioplegia

Group Type ACTIVE_COMPARATOR

del nido cardioplegia

Intervention Type OTHER

Interventions

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blood cardioplegia

Intervention Type OTHER

del nido cardioplegia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Tetralogy of fallot

Exclusion Criteria

* TOF with absent pulmonary valve , TOF with pulmonary atresia
Minimum Eligible Age

1 Year

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SUNDER LAL NEGI

UNKNOWN

Sponsor Role lead

Responsible Party

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SUNDER LAL NEGI

Fellow, Cardiac anesthesia.

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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NK/1840/DM/16940

Identifier Type: -

Identifier Source: org_study_id

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