drugset / Trial / NCT03876067

The Cardioprotective Effects of Adding Ozone To Cardioplegic Solution in Adult Cardiac Surgery

NCT03876067

Phase 2/3 Unknown 40 enrolled Assiut University
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

forty patients with age ranged between 40-70 years undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass will be included, they will divided into two groups. Ozone Group: in which Ozone will be added to cold blood cardioplegia. Control Group: in which in which only cold blood cardioplegia Primary outcome: Pattern of recovery of myocardium after declamping of Aorta 1. Time of cardiac rhythm return after declamping. 2. type of cardiac rhythm after declamping and rate of DC use. Secondary outcome: A-cardiac parameters * Post operative inotropic score * Incidence of post operative cardiac dysrhythmias * postoperative ejection fraction (EF) * Postoperative parameters of myocardial ischaemia * a- Troponin levels * b-Pro BNP * • Histopathology of myocardial sample for detection of myocyte cellular edema as a marker of ischemic changes. B-non cardiac parameters: 1. inflammatory markers 1. CRP 2. L\\N 3. P\\N 2. ICU stay 3. hospital stay 4. morbidity and mortality

Timeline

Start
2019-04-01
Primary completion
2022-03
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ozone Other / unclassified 50 ml

Indications