Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Ischemic Heart Disease
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 40 years and 70 years
Gender
Both males and females

Description

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 transfusi...

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

Tracking Information

NCT #
NCT03876067
Collaborators
Not Provided
Investigators
Not Provided