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Completed

NCT Number: NCT02646254

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

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

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Key information

Conditions

Myocardial Protection in TOF Repair Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Age range

1 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tetralogy of fallot

Exclusion criteria

  • TOF with absent pulmonary valve , TOF with pulmonary atresia

Treatment and study plan

blood cardioplegia

Other

del nido cardioplegia

Other

Primary outcomes

  1. inotropic score

    Time frame: First 24 hours

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

    Time frame: 72hrs

  3. resumption of spontaneous rhythm after aortic cross clamp off

    Time frame: 10 minutes

Secondary outcomes

  1. duration of mechanical ventilation in hours

    Time frame: 48 hours

  2. ICU stay

    Time frame: 7 days

  3. hospital mortality

    Time frame: 30 days

  4. echocardiographic assessment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

SUNDER LAL NEGI

Unknown

Registry information

Official study title

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

Acronym: TOF

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2016
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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