Myocardial IschemiaNCT02715869
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
A study testing A pharmacologic cardiac preconditioning (Sevoflurane) and B ischeamic preconditioning in people with Myocardial Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- A pharmacologic cardiac preconditioning (Sevoflurane) and B ischeamic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Jun 2017
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
Who cannot join
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (>120 min)
- Patients required intra-aortic balloon pump
- Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Trial locations and contacts
1 site in 1 country.
About this study
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).
Read the detailed description
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)
Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)
Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury
Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality
Aim of the work:
Is to validate the impact of Sevoflurane versus ischemic \& Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery
- Conditions
- Myocardial Ischemia
- Being tested
- A pharmacologic cardiac preconditioning (Sevoflurane), B ischeamic preconditioning
- Keywords
- Myocardial Preconditioning, inotropic score
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A pharmacologic cardiac preconditioning (Sevoflurane)Drug
A Patients are anaesthetized by Sevoflurane more than 1 mac.
B ischeamic preconditioningProcedure or surgery
B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
| Study group | Role | What they receive |
|---|---|---|
| A pharmacologic cardiac preconditioning | Active comparator | Sevoflurane as a pharmacologic preconditioner for the heart Receives: Drug: A pharmacologic cardiac preconditioning (Sevoflurane) |
| B ischeamic preconditioning | Active comparator | ischemic preconditioning by inflation the cuff of blood pressure Receives: Procedure: B ischeamic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest inotropic score
Measured: first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
- Investigators
- Emad Zarief Kamel Said, M.D., Study director, Department of Anesthesia, faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715869
- Sponsor's protocol ID
- IRB00009901
- Status last verified
- Dec 2017
- First submitted
- 17 Mar 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02715869
- Acronym / sponsor ID
- IRB00009901
- Conditions
- Myocardial Ischemia
- Keywords
- Myocardial Preconditioning, inotropic score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Mar 2016 (estimated)
- 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.
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).
Detailed description
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)
Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)
Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury
Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality
Aim of the work:
Is to validate the impact of Sevoflurane versus ischemic \& Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A pharmacologic cardiac preconditioning | Active comparator | Drug: A pharmacologic cardiac preconditioning (Sevoflurane)Sevoflurane as a pharmacologic preconditioner for the heart |
| B ischeamic preconditioning | Active comparator | Procedure: B ischeamic preconditioningischemic preconditioning by inflation the cuff of blood pressure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
Key exclusion criteria (6 listed)
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (>120 min)
- Patients required intra-aortic balloon pump
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 |
|---|---|---|
| A pharmacologic cardiac preconditioning (Sevoflurane)A Patients are anaesthetized by Sevoflurane more than 1 mac. | Drug | A pharmacologic cardiac preconditioning |
| B ischeamic preconditioningB ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles | Procedure or surgery | B ischeamic preconditioning |
Primary outcome
Highest inotropic score
Time frame: first 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Emad Zarief Kamel Said, M.D. study director
Department of Anesthesia, faculty of Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A pharmacologic cardiac preconditioning (Sevoflurane) and B ischeamic preconditioning in people with Myocardial Ischemia, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Highest inotropic score (time frame: first 24 hour). 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 12 Dec 2017.