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

Myocardial Protection in TOF Repair Clinical Trial

— TOF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646254
• Other study ID #: NK/1840/DM/16940
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2015
• Last updated: December 31, 2015
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 50 Years

Eligibility

Inclusion Criteria:

• Tetralogy of fallot

Exclusion Criteria:

• TOF with absent pulmonary valve , TOF with pulmonary atresia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myocardial Protection in TOF Repair
• Tetralogy of Fallot

Intervention

Other:
• blood cardioplegia

• del nido cardioplegia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SUNDER LAL NEGI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inotropic score		First 24 hours	No
Primary	Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours		72hrs	No
Primary	resumption of spontaneous rhythm after aortic cross clamp off		10 minutes	No
Secondary	duration of mechanical ventilation in hours		48 hours	No
Secondary	ICU stay		7 days	No
Secondary	hospital mortality		30 days	No
Secondary	echocardiographic assessment		6 months	No