Remote Preconditioning and Myocardial Protection

NCT02877238 | Completed Phase 2 DMC

• 1 other identifier: IIRB0000871234
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

remote ischemic preconditioning; sevoflurane; total intravenous anesthetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Highest inotropic score during the first 24 hours after cardiac surgery

  within first 24 hours after cardiac surgery

• Mortality at 30 days

  30 days

• Cardiac function

  within first 24 hours of cardiac surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Sevoflurane plus remote ischemic preconditioning

Group B

ACTIVE COMPARATOR

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

Drug: Total intravenous anesthesia plus remote ischemic preconditioning

Interventions

Sevoflurane plus remote ischemic preconditioning DRUG

Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning

Also known as: Group A

Group A

Total intravenous anesthesia plus remote ischemic preconditioning DRUG

Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning

Also known as: Group B

Group B

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Sayed K Abd-Elshafy, MD

  Associate professor of anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate profossor of anesthesia

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

EG (1)