Ischemic Heart DiseasePhase 2/3NCT03876067
The Cardioprotective Effects of Adding Ozone To Cardioplegic Solution in Adult Cardiac Surgery
A Phase 2/3 study testing Ozone and Cardioplegic Solutions in people with Ischemic Heart Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Ozone and Cardioplegic Solutions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective CABG surgery
Who cannot join
- • 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
About this study
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
Read more
Primary outcome:
Pattern of recovery of myocardium after declamping of Aorta
- Time of cardiac rhythm return after declamping.
- 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:
- inflammatory markers 1. CRP 2. L\N 3. P\N
- ICU stay
- hospital stay
- morbidity and mortality
Read the detailed 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 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
- Conditions
- Ischemic Heart Disease
- Being tested
- Ozone, Cardioplegic Solutions
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
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
Cardioplegic SolutionsDrug
in which in which only cold blood cardioplegia
| Study group | Role | What they receive |
|---|---|---|
| Ozone Group | Experimental | in which Ozone will be added to cold blood cardioplegia Receives: Drug: Ozone |
| Control Group | Placebo comparator | : in which in which only cold blood cardioplegia Receives: Drug: Cardioplegic Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of cardiac rhythm
Time of cardiac rhythm return after declamping.
Measured: one hour
type of cardiac rhythm
type of cardiac rhythm after declamping and rate of DC use
Measured: one hour
Secondary outcomes (6)
Post operative inotropic score
Post operative inotropic score
Measured: two weeks
post operativecardiac dysrhythmias
Incidence of post operativecardiac dysrhythmias
Measured: two weeks
postoperative ejection fraction (EF)
postoperative ejection fraction (EF)
Measured: one month
Postoperative parameters of myocardial ischaemia
Troponin levels
Measured: two weeks
ICU stay
ICU stay
Measured: two weeks
mortality
mortality
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israa mohamed lotfallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876067
- Sponsor's protocol ID
- AssuitUlotfallah
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardioprotective Effects of Adding Ozone To Cardioplegic Solution in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03876067
- Acronym / sponsor ID
- AssuitUlotfallah
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Time of cardiac rhythm return after declamping.
- 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:
- inflammatory markers 1. CRP 2. L\N 3. P\N
- ICU stay
- hospital stay
- morbidity and mortality
Detailed 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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone Group | Experimental | Drug: Ozonein which Ozone will be added to cold blood cardioplegia |
| Control Group | Placebo comparator | Drug: Cardioplegic Solutions: in which in which only cold blood cardioplegia |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective CABG surgery
Key exclusion criteria (7 listed)
- • left ventricular ejection fraction< 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzoneOur 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 | Ozone Group |
| Cardioplegic Solutionsin which in which only cold blood cardioplegia | Drug | Control Group |
Primary outcome
Time of cardiac rhythm
Time frame: one hour
Time of cardiac rhythm return after declamping.
type of cardiac rhythm
Time frame: one hour
type of cardiac rhythm after declamping and rate of DC use
6 secondary outcomes
Post operative inotropic score
Time frame: two weeks
post operativecardiac dysrhythmias
Time frame: two weeks
postoperative ejection fraction (EF)
Time frame: one month
Postoperative parameters of myocardial ischaemia
Time frame: two weeks
ICU stay
Time frame: two weeks
mortality
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ozone and Cardioplegic Solutions in people with Ischemic Heart Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of cardiac rhythm (time frame: one hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.