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

December 31, 2015 updated by: SUNDER LAL NEGI

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tetralogy of fallot

Exclusion Criteria:

  • TOF with absent pulmonary valve , TOF with pulmonary atresia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: blood cardioplegia
these patients received blood cardioplegia
Other: blood cardioplegia
ACTIVE_COMPARATOR: del nido cardioplegia
these patients received del nido cardioplegia
Other: del nido cardioplegia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of mechanical ventilation in hours
Time Frame: 48 hours
48 hours
ICU stay
Time Frame: 7 days
7 days
hospital mortality
Time Frame: 30 days
30 days
echocardiographic assessment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SUNDER LAL NEGI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (ESTIMATE)

January 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/1840/DM/16940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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