Cardiac SurgeryIPICSNCT01813968
Ischemic Postconditioning in Cardiac Surgery
A study testing Ischemic postconditioning in people with Cardiac Surgery, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Ischemic postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to 5 Jun 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgery of the ascending aorta or the aortic valve
- -
Who cannot join
- Coronary artery disease requiring bypass surgery
- Tricuspid valve surgery
- Mitral valve surgery
- Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
- Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
- Patients with autoimmune diseases
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- "Redo" operations
- Active endocarditis (ongoing antibiotic therapy)
- On the discretion of the operating surgeon or anaesthesiologist
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål
Oslo, 0424
About this study
Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.
Read the detailed description
Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients > 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.
The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.
- Conditions
- Cardiac Surgery
- Being tested
- Ischemic postconditioning
- Keywords
- Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Swan-Ganz, Cardiac index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic postconditioningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ischemic postconditioning | Experimental | Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3 Receives: Procedure: Ischemic postconditioning |
| Control | No intervention | Standard operating technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac index between the groups during the first postoperative day
Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
Measured: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw, University Hospital of North Norway, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Responsible party
- Principal investigator, Mari-Liis Kaljusto, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813968
- Sponsor's protocol ID
- 2011/2613
- Acronym
- IPICS
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2013
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Postconditioning in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01813968
- Acronym / sponsor ID
- IPICS / 2011/2613
- Conditions
- Cardiac Surgery
- Keywords
- Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Swan-Ganz, Cardiac index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Medical University of Warsaw, University Hospital of North Norway, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Study start
- Jan 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 19 Mar 2013 (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.
Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.
Detailed description
Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients > 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.
The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic postconditioning | Experimental | Procedure: Ischemic postconditioningIschemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3 |
| Control | No intervention | –Standard operating technique |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective surgery of the ascending aorta or the aortic valve
- -
Key exclusion criteria (9 listed)
- Coronary artery disease requiring bypass surgery
- Tricuspid valve surgery
- Mitral valve surgery
- Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
- Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
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 postconditioning | Procedure or surgery | Ischemic postconditioning |
Primary outcome
Change in cardiac index between the groups during the first postoperative day
Time frame: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
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 15 Dec 2023.
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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 postconditioning in people with Cardiac Surgery, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 9 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 15 Dec 2023. 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 Norway. 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?
Change in cardiac index between the groups during the first postoperative day (time frame: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively). 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 15 Dec 2023.