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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
Secondary outcome:
A-cardiac parameters
B-non cardiac parameters:
Ozone Administration Protocol
Our procedures for O3T application in CBP surgery conform to international guidelines of the ''Madrid Declaration on Ozone Therapy'' 32 . M-O3T will be carried out as follows:
50mL of blood drawn by vacuum from the patient central catheter into a sterile blood transfusion bag in which 10 mL of 3.8% Na citrate solution (Galenica Senese Industries, Siena, Italy) as an anticoagulant will be previously added so that the blood/citrate volume ratio was 9:1. After blood withdrawal, the bag will momentarily disconnected leaving the venous access open by a saline infusion 33 . A corresponding volume (50 mL) of gas was immediately added with an O3 concentration of 20-50 micrograms/mL gas. Ozone was produced by Medozon compact generator (Herrmann Apparatebau GmbH, Germany).
The gas is immediately and continuously mixed with the blood in the bag for at least 5 min and with gentle rotating movement to avoid foaming. Due to the blood viscosity, the gas mixture does not instantaneously come into contact with the whole blood mass, thus this mixing time is necessary. During these 5 min of mixing, the ozone totally reacted with both the potent antioxidants of plasma and the unsaturated lipids bound to albumin, generating asmall amount of hydrogen peroxide and alkenals. These two messengers were responsible for eliciting crucial biochemical reactions on both erythrocytes and within cells. At this point, the hyper-oxygenated ozonated blood will be mixed with the cold cardioplegia (Thomsons cardioplegia) this amount of ozonated blood will be added to each 500 ml of cardioplegic solution
Exclusion Criteria:
The patient will be excluded from the study if he has any of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone Group | Experimental | in which Ozone will be added to cold blood cardioplegia |
|
| Control Group | Placebo Comparator | : in which in which only cold blood cardioplegia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Drug | Our procedures for O3T application in CBP surgery conform to international guidelines of the ''Madrid Declaration on Ozone Therapy'' 32 . M-O3T will be carried out as follows: 50mL of blood drawn by vacuum from the patient central catheter into a sterile blood transfusion bag in which 10 mL of 3.8% Na citrate solution (Galenica Senese Industries, Siena, Italy) as an anticoagulant will be previously added so that the blood/citrate volume ratio was 9:1. After blood withdrawal, the bag will momentarily disconnected leaving the venous access open by a saline infusion 33 . A corresponding volume (50 mL) of gas was immediately added with an O3 concentration of 20-50 micrograms/mL gas. Ozone was produced by Medozon compact generator (Herrmann Apparatebau GmbH, Germany). At this point, the hyper-oxygenated ozonated blood will be mixed with the cold cardioplegia (Thomsons cardioplegia) this amount of ozonated blood will be added to each 500 ml of cardioplegic solution |
| Measure | Description | Time Frame |
|---|---|---|
| Time of cardiac rhythm | Time of cardiac rhythm return after declamping. | one hour |
| type of cardiac rhythm | type of cardiac rhythm after declamping and rate of DC use | one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative inotropic score | Post operative inotropic score | two weeks |
| post operativecardiac dysrhythmias | Incidence of post operativecardiac dysrhythmias |
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Inclusion Criteria:
Exclusion Criteria:
• left ventricular ejection fraction< 40%
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010126 | Ozone |
| D002314 | Cardioplegic Solutions |
| ID | Term |
|---|---|
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D019999 | Pharmaceutical Solutions |
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|
| Cardioplegic Solutions | Drug | in which in which only cold blood cardioplegia |
|
| two weeks |
| postoperative ejection fraction (EF) | postoperative ejection fraction (EF) | one month |
| Postoperative parameters of myocardial ischaemia | Troponin levels | two weeks |
| ICU stay | ICU stay | two weeks |
| mortality | mortality | two weeks |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |