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

NCT03876067 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-19

No results posted yet for this study

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

Conditions

  • Ischemic Heart Disease

Interventions

DRUG

Ozone

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

DRUG

Cardioplegic Solutions

in which in which only cold blood cardioplegia

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-03-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876067 on ClinicalTrials.gov