Open Heart SurgeryNCT03105089
Effect of Cardiac Preconditioning Upon the Inotrope Score
A study testing ischemic preconditioning in people with Open Heart Surgery and Preconditioning, run by Assiut University at 1 site in Egypt.
Trial summary
preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Open Heart Surgery, Preconditioning
- What is being tested?
- ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to May 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adult patient
- valve replacement surgery
- ASA grade 2 or 3
Who cannot join
- emergency surgery
- - poor general conditions
- impaired hepatic or renal function
- peripheral vascular disease
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support
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 mobidity and mortality
- Conditions
- Open Heart Surgery, Preconditioning
- Being tested
- ischemic preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic preconditioningProcedure or surgery
) 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 |
|---|---|---|
| ischemic preconditioning | Active comparator | 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 Receives: Procedure: ischemic preconditioning |
| control | No intervention | no intervention will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
inotropic score
Measured: 48 hours
Secondary outcomes (1)
renal function
serum creatinine
Measured: 2 dyas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startMar 2016
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105089
- Sponsor's protocol ID
- IRB00009910
- Status last verified
- Oct 2017
- First submitted
- 2 Apr 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 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
- NCT03105089
- Acronym / sponsor ID
- IRB00009910
- Conditions
- Open Heart Surgery, Preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Apr 2017 (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.
preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support
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 mobidity and mortality
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ischemic preconditioning | Active comparator | Procedure: ischemic preconditioningischemic 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 |
| control | No intervention | –no intervention will be done |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adult patient
- valve replacement surgery
- ASA grade 2 or 3
Key exclusion criteria (5 listed)
- emergency surgery
- - poor general conditions
- impaired hepatic or renal function
- peripheral vascular disease
- patient refusal
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 |
|---|---|---|
| ischemic preconditioning) 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 | ischemic preconditioning |
Primary outcome
inotropic score
Time frame: 48 hours
1 secondary outcome
renal function
Time frame: 2 dyas
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 30 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ischemic preconditioning in people with Open Heart Surgery and Preconditioning, 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 5 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 30 Oct 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?
inotropic score (time frame: 48 hours). 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 30 Oct 2017.