Remote Preconditioning and Myocardial Protection

Congenital Heart Disease Clinical Trial

Official title:

Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877238
• Other study ID #: IIRB0000871234
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2016
• Last updated: December 11, 2017
• Start date: August 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Drug:
• Sevoflurane plus remote ischemic preconditioning
Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning
• Total intravenous anesthesia plus remote ischemic preconditioning
Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I levels	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.	within first 24 hours after cardiac surgery
Secondary	Highest inotropic score during the 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	within first 24 hours after cardiac surgery
Secondary	Mortality at 30 days	Proportion of patients who dies within 30 days of their surgical repair	30 days
Secondary	Cardiac function	Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation	within first 24 hours of cardiac surgery