Congenital Heart DiseasePhase 2NCT02877238
Remote Preconditioning and Myocardial Protection
A Phase 2 study testing Sevoflurane plus remote ischemic preconditioning and Total intravenous anesthesia plus remote ischemic preconditioning in people with Congenital Heart Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Sevoflurane plus remote ischemic preconditioning and Total intravenous anesthesia plus remote ischemic preconditioning
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to May 2017
- Phase
- Phase 2
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass
Who cannot join
- Previous cardiac surgery
- Urgent or emergent cases
- Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.
Read the detailed description
The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.
- Conditions
- Congenital Heart Disease
- Being tested
- Sevoflurane plus remote ischemic preconditioning, Total intravenous anesthesia plus remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, sevoflurane, total intravenous anesthetic
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane plus remote ischemic preconditioningDrug
Also called Group A
Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning
Total intravenous anesthesia plus remote ischemic preconditioningDrug
Also called Group B
Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles Receives: Drug: Sevoflurane plus remote ischemic preconditioning |
| Group B | Active comparator | anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles Receives: Drug: Total intravenous anesthesia plus remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I levels
The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
Measured: within first 24 hours after cardiac surgery
Secondary outcomes (3)
Highest inotropic score during the first 24 hours after cardiac surgery
Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery.
The inotropic score is calculated as follows: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. Inotrope score is a useful predictor of morbidity and mortality in children who undergo heart surgery
Measured: within first 24 hours after cardiac surgery
Mortality at 30 days
Proportion of patients who dies within 30 days of their surgical repair
Measured: 30 days
Cardiac function
Cardiac rhythm on return if it will be sinus rhythm or return with ventricular fibrillation
Measured: within first 24 hours of cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 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 Congenital 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed K Abd-Elshafy, MD, Principal investigator, Associate professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877238
- Sponsor's protocol ID
- IIRB0000871234
- Status last verified
- Dec 2017
- First submitted
- 15 Aug 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
- ClinicalTrials.gov ID
- NCT02877238
- Acronym / sponsor ID
- IIRB0000871234
- Conditions
- Congenital Heart Disease
- Keywords
- remote ischemic preconditioning, sevoflurane, total intravenous anesthetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Aug 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.
Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.
Detailed description
The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Sevoflurane plus remote ischemic preconditioningSevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles |
| Group B | Active comparator | Drug: Total intravenous anesthesia plus remote ischemic preconditioninganesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Previous cardiac surgery
- Urgent or emergent cases
- Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
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 |
|---|---|---|
| Sevoflurane plus remote ischemic preconditioningAlso: Group AInhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning | Drug | Group A |
| Total intravenous anesthesia plus remote ischemic preconditioningAlso: Group BTotal intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning | Drug | Group B |
Primary outcome
Troponin I levels
Time frame: within first 24 hours after cardiac surgery
The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
3 secondary outcomes
Highest inotropic score during the first 24 hours after cardiac surgery
Time frame: within first 24 hours after cardiac surgery
Mortality at 30 days
Time frame: 30 days
Cardiac function
Time frame: within first 24 hours of cardiac surgery
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 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
Not yet recruitingObservational study
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
Neonatal Congenital Heart Disease
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.
Sayed K Abd-Elshafy, MD principal investigator
Associate professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevoflurane plus remote ischemic preconditioning and Total intravenous anesthesia plus remote ischemic preconditioning in people with Congenital Heart Disease, 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 1 inclusion and 3 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 13 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Troponin I levels (time frame: within first 24 hours after cardiac surgery). 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 13 Dec 2017.