The Cardioprotective Effects of Adding Ozone To Cardioplegic Solution in Adult Cardiac Surgery
Słowa kluczowe
Abstrakcyjny
Opis
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:
- left ventricular ejection fraction< 40%
- diabetic or other metabolic disorders,
- use of left ventricular assist devices,
- Renal failure or on hemodialysis
- Hepatic dysfunction
- Hypothyroidism
- implanted pacemaker
Daktyle
| Ostatnia weryfikacja: | 02/28/2019 |
| Pierwsze przesłane: | 03/09/2019 |
| Szacowana liczba przesłanych rejestracji: | 03/13/2019 |
| Wysłany pierwszy: | 03/14/2019 |
| Ostatnia aktualizacja przesłana: | 03/15/2019 |
| Ostatnia opublikowana aktualizacja: | 03/18/2019 |
| Rzeczywista data rozpoczęcia badania: | 03/31/2019 |
| Szacowana data zakończenia podstawowej działalności: | 02/28/2022 |
| Szacowana data zakończenia badania: | 11/30/2022 |
Stan lub choroba
Interwencja / leczenie
Drug: Ozone Group
Drug: Control Group
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: Ozone Group in which Ozone will be added to cold blood cardioplegia | Drug: Ozone Group 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 |
| Placebo Comparator: Control Group : in which in which only cold blood cardioplegia | Drug: Control Group in which in which only cold blood cardioplegia |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 40 Years Do 40 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - patients undergoing elective CABG surgery Exclusion Criteria: - • left ventricular ejection fraction< 40% - diabetic or other metabolic disorders, - use of left ventricular assist devices, - Renal failure or on hemodialysis - Hepatic dysfunction - Hypothyroidism - implanted pacemaker |
Wynik
Podstawowe miary wyników
1. Time of cardiac rhythm [one hour]
2. type of cardiac rhythm [one hour]
Miary wyników wtórnych
1. Post operative inotropic score [two weeks]
2. post operativecardiac dysrhythmias [two weeks]
3. postoperative ejection fraction (EF) [one month]
4. Postoperative parameters of myocardial ischaemia [two weeks]
5. ICU stay [two weeks]
6. mortality [two weeks]
