Remote Preconditioning and Myocardial Protection

Phase 2

Completed

• Conditions: Congenital Heart Disease
• Interventions: Drug: Sevoflurane plus remote ischemic preconditioning; Drug: Total intravenous anesthesia plus remote ischemic preconditioning

• Registration Number: NCT02877238
• Lead Sponsor: Assiut University

Brief Summary

Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

Detailed Description

The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass

Exclusion Criteria

• Previous cardiac surgery
• Urgent or emergent cases
• Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Sevoflurane plus remote ischemic preconditioning	Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
Group B	Total intravenous anesthesia plus remote ischemic preconditioning	anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles

Primary Outcome Measures

Name	Time	Method
Troponin I levels	within first 24 hours after cardiac surgery	The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.

Secondary Outcome Measures

Name	Time	Method
Mortality at 30 days	30 days	Proportion of patients who dies within 30 days of their surgical repair
Highest inotropic score during the first 24 hours after cardiac surgery	within first 24 hours after cardiac surgery	Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.; The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery
Cardiac function	within first 24 hours of cardiac surgery	Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt