Vascular SurgeryNCT02254642
Effects of Ischemic Preconditioning After Aortic Clamping
A study testing Ischemic preconditioning during aortic clamping and Procedure/Surgery: usual surgery in people with Vascular Surgery and Ischemia-reperfusion, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Surgery, Ischemia-reperfusion, Ischemia Preconditioning
- What is being tested?
- Ischemic preconditioning during aortic clamping and Procedure/Surgery: usual surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Nov 2018to 15 Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
- Patients who received clear information, with signed consent
- Patients 18 to 85 years
Who cannot join
- Patients under guardianship
- No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
- Pregnancy, lactation
- Hemodialysis
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Chirurgie Vasculaire, CH Jean Minjoz
Besançon, 25030
Service de Chirurgie Vasculaire, CHU le Bocage
Dijon, 21079
Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy
Vantoux, 57070
About this study
Official title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.
- Being tested
- Ischemic preconditioning during aortic clamping, Procedure/Surgery: usual surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioning during aortic clampingProcedure or surgery
Ischemic preconditioning during aortic clamping
Procedure/Surgery: usual surgeryProcedure or surgery
Procedure/Surgery: usual surgery
| Study group | Role | What they receive |
|---|---|---|
| Ischemic preconditioning arm | Experimental | Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping. Receives: Procedure: Ischemic preconditioning during aortic clamping |
| Control patients | Other | Usual surgery assigned to control patients Receives: Procedure: Procedure/Surgery: usual surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
Myocardial damage measured by Troponin I level > 0.4 microg/L
Measured: Day 1
Secondary outcomes (3)
Renal damage
Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance
Measured: Day 0, day 1, day 3 or day 5.
Muscle weakness
Muscle weakness measured by Creatine phospho Kinase > 200 UI/L
Measured: Day 0, day 1, day 3 or day 5
Myocardial damage measured by troponin level > 0.4 microgr/L
Measured: Day 0, 3, or 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start20 Nov 2018
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular SurgeryStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lejay, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254642
- Sponsor's protocol ID
- 5831
- Status last verified
- Apr 2022
- First submitted
- 26 Jun 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
- ClinicalTrials.gov ID
- NCT02254642
- Acronym / sponsor ID
- 5831
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 2 Oct 2014 (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.
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic preconditioning arm | Experimental | Procedure: Ischemic preconditioning during aortic clampingPatients will have the ischemic preconditioning protocol 1 hour before the aortic clamping. |
| Control patients | Other | Procedure: Procedure/Surgery: usual surgeryUsual surgery assigned to control patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
- Patients who received clear information, with signed consent
- Patients 18 to 85 years
Key exclusion criteria (4 listed)
- Patients under guardianship
- No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
- Pregnancy, lactation
- Hemodialysis
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 during aortic clampingIschemic preconditioning during aortic clamping | Procedure or surgery | Ischemic preconditioning arm |
| Procedure/Surgery: usual surgeryProcedure/Surgery: usual surgery | Procedure or surgery | Control patients |
Primary outcome
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
Time frame: Day 1
Myocardial damage measured by Troponin I level > 0.4 microg/L
3 secondary outcomes
Renal damage
Time frame: Day 0, day 1, day 3 or day 5.
Muscle weakness
Time frame: Day 0, day 1, day 3 or day 5
Myocardial damage measured by troponin level > 0.4 microgr/L
Time frame: Day 0, 3, or 5
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
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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.
Anne Lejay, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic preconditioning during aortic clamping and Procedure/Surgery: usual surgery in people with Vascular Surgery and Ischemia-reperfusion, run by University Hospital, Strasbourg, France at 4 sites in France.
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 4 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: stopped early, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was stopped early (reason given: recruitment difficulties). 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?
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254642, which also lists 1 linked publication.
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 27 Apr 2022.