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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02646254

Acronym

TOF

Enrollment

Registered

2016-01-05

Start date

2014-06-30

Completion date

2015-10-31

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Protection in TOF Repair

Keywords

tetralogy of fallot, cardioplegia

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.

Interventions

OTHERblood cardioplegia

OTHERdel nido cardioplegia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Tetralogy of fallot

Exclusion criteria

* TOF with absent pulmonary valve , TOF with pulmonary atresia

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026