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

NCT03876067 | Unknown Phase 2

• 1 other identifier: AssuitUlotfallah
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

• 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:
• inflammatory markers 1. CRP 2. L\\N 3. P\\N
• ICU stay
• hospital stay
• morbidity and mortality

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Post operative inotropic score

  two weeks

• post operativecardiac dysrhythmias

  two weeks

• postoperative ejection fraction (EF)

  one month

• Postoperative parameters of myocardial ischaemia

  two weeks

• ICU stay

  two weeks

Study Arms (2)

Ozone Group

EXPERIMENTAL

in which Ozone will be added to cold blood cardioplegia

Drug: Ozone

Control Group

PLACEBO COMPARATOR

: in which in which only cold blood cardioplegia

Drug: Cardioplegic Solutions

Interventions

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

Ozone Group

Cardioplegic Solutions DRUG

in which in which only cold blood cardioplegia

Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective CABG surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Ozone; Cardioplegic Solutions

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture assiut university hospital principle investigator

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 15, 2019
• Study Start: April 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 19, 2019

Record last verified: 2019-03