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Completed

NCT Number: NCT02877238

Remote Preconditioning and Myocardial Protection

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

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane plus remote ischemic preconditioning

Drug

Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning

Other names: Group A

Total intravenous anesthesia plus remote ischemic preconditioning

Drug

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

Other names: Group B

Primary outcomes

  1. Troponin I levels

    Time frame: 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 outcomes

  1. Highest inotropic score during the first 24 hours after cardiac surgery

    Time frame: 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

  2. Mortality at 30 days

    Time frame: 30 days

    Proportion of patients who dies within 30 days of their surgical repair

  3. Cardiac function

    Time frame: within first 24 hours of cardiac surgery

    Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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