Aneurysm AorticEPAKINCT07441564
Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Juxtarenal Abdominal Aortic Aneurysm
A study testing patients with aortic clamping with preconditioning and patients with aortic clamping without preconditioning in people with Aneurysm Aortic, run by University Hospital, Rouen at 7 sites in France.
Trial summary
Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries. Open surgical repair continues to be used in patients unsuitable for EVAR but carries a high risk of acute kidney injury (AKI), up to 24%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aneurysm Aortic
- What is being tested?
- patients with aortic clamping with preconditioning and patients with aortic clamping without preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Sep 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 18-85 years
- Patients with juxtarenal abdominal aortic aneurysms scheduled for open surgery
- Patients with juxtarenal abdominal aortic aneurysms, which require suprarenal aortic cross clamping
- Patients with juxtarenal abdominal aortic aneurysms, which are of atheromatous etiology or which developed after aortic dissection
- Affiliation with, or beneficiary of a Social security (national health insurance) scheme
- Adult having read and understood the information letter and signed the consent form
Show all 9Show fewer
- Women of childbearing potential with effective contraception according WHO definition (estrogen-progestin contraception or intrauterine device or male condom) since at least 1 month with a negative blood pregnancy test by b-HCG at inclusion.
- Women surgically sterile (absence of ovaries and/or uterus or tubal ligation)
- Postmenopausal women: confirmation of non-medically induced amenorrhea since at least 12 months prior to the inclusion visit
Who cannot join
- Patients dependent from dialysis
- Patients with aortic aneurysms, which require reconstruction of the visceral arteries
- Patients with aortic aneurysms, which require supra-visceral aortic cross clamping
- Patients with wall thrombus or calcification of inter- and suprarenal aorta
- Patients with septic aortitis
- Patients with aneurysm requiring stent graft (EVAR) explantation
Show all 12Show fewer
- Patients requiring emergency surgery
- Patients receiving treatments that may interact with preconditioning: Nicorandil and Glibenclamide
- Pregnant or parturient or breastfeeding woman or absence of proven contraception
- Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or curatorship
- Person participating to another trial during the month before randomization
- Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his/her participation to the protocol or unable to give an informed consent
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHU de DIJON
Dijon, 21000
Eric Steinmetz, Pr, 03 80 29 33 52, eric.steinmetz@chu-dijon.fr
Eric Steinmetz, Pr
CHU de LILLE
Lille, 59000
Jonathan Sobocinsky, Pr, 03 20 44 59 62, Jonathan.SOBOCINSKI@chu-lille.fr
Jonathan Sobocinsky, Pr
CHU de NANCY
Nancy, 54511
Serguei Malikof, Pr, 03 83 15 30 64, s.malikov@chru-nancy.fr
Serguei Malikof, Pr
CHU de NANTES
Nantes, 44093
Blandine Morel, Pr, 02 40 16 50 93, blandine.maurel@chu-nantes.fr
Blandine Morel, Pr
Ap-Hp La Pitie
Paris, 75013
Laurent Chiche, Pr, 01 42 17 57 07, laurent.chiche@aphp.fr
Laurent Chiche, Pr
CHU de ROUEN
Rouen, 76031
Didier Plissonnier, Pr, 02 32 88 66 31, didier.plissonnier@chu-rouen.fr
Didier Plissonnier, Dr
CHU de TOULOUSE
Toulouse, 31400
Xavier Chaufour, Pr, 05 61 32 39 10, chaufour.x@chu-toulouse.fr
Xavier Chaufour, Pr
About this study
Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries. Open surgical repair continues to be used in patients unsuitable for EVAR but carries a high risk of acute kidney injury (AKI), up to 24%. Postoperative AKI is a strong predictor of both short- and long-term cardiovascular mortality. The KDIGO criteria are used to better define and stage AKI. Pharmacological prevention strategies have shown limited effectiveness, prompting interest in ischemic preconditioning (IPC). Remote IPC has shown mixed results in cardiac and vascular surgery, depending on patient risk and protocols used. Local IPC, applied directly near the renal arteries, has shown promising renal protection in animal models. However, this technique has never been clinically tested in humans. We propose here a randomized trial to assess the efficacy of local IPC before suprarenal aortic clamping during open repair of juxta-renal AAA to reduce postoperative AKI.
- Conditions
- Aneurysm Aortic
- Being tested
- patients with aortic clamping with preconditioning, patients with aortic clamping without preconditioning
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with aortic clamping with preconditioningProcedure or surgery
Experimental group (arm 1) consists of patients receiving open juxtarenal aortic aneurysm surgery with direct preconditioning by clamping the suprarenal aorta, which starts after randomization. The procedure for IPC will be achieved by two cycles of supra-renal aortic cross clamping during 5 minutes followed by an unclamping period of 5 minutes before starting the supra-renal aortic cross clamping needed to perform surgery. The level of aortic cross clamping used for IPC will be that required for aortic repair.
patients with aortic clamping without preconditioningProcedure or surgery
Control group (arm 2) consists of patients receiving open juxtarenal aortic aneurysm surgery without preconditionning
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental group: | Experimental | patients with aortic clamping with preconditioning Receives: Procedure: patients with aortic clamping with preconditioning |
| Arm 2 - Control group: | Other | patients with aortic clamping without preconditioning Receives: Procedure: patients with aortic clamping without preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of ischemic preconditioning (IPC) applied closely to the supra-renal aorta with respect to the occurrence of Acute Kidney Injury (AKI) among patients undergoing open juxtarenal aortic aneurysm surgery.
The primary endpoint is the occurrence of a postoperative AKI of stage > 1 before the morning visit on day 8. We use the KDIGO work group's definition of AKI.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AorticStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prognostic, prospective, comparative, randomized, open, multi-centre, national study
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441564
- Sponsor's protocol ID
- 2023/0298/HP
- Other IDs
- 2024-A01808-39
- Acronym
- EPAKI
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Juxtarenal Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT07441564
- Acronym / sponsor ID
- EPAKI / 2023/0298/HP
- Conditions
- Aneurysm Aortic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 2 Mar 2026 (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.
Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries. Open surgical repair continues to be used in patients unsuitable for EVAR but carries a high risk of acute kidney injury (AKI), up to 24%. Postoperative AKI is a strong predictor of both short- and long-term cardiovascular mortality. The KDIGO criteria are used to better define and stage AKI. Pharmacological prevention strategies have shown limited effectiveness, prompting interest in ischemic preconditioning (IPC). Remote IPC has shown mixed results in cardiac and vascular surgery, depending on patient risk and protocols used. Local IPC, applied directly near the renal arteries, has shown promising renal protection in animal models. However, this technique has never been clinically tested in humans. We propose here a randomized trial to assess the efficacy of local IPC before suprarenal aortic clamping during open repair of juxta-renal AAA to reduce postoperative AKI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prognostic, prospective, comparative, randomized, open, multi-centre, national study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Experimental group: | Experimental | Procedure: patients with aortic clamping with preconditioningpatients with aortic clamping with preconditioning |
| Arm 2 - Control group: | Other | Procedure: patients with aortic clamping without preconditioningpatients with aortic clamping without preconditioning |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18-85 years
- Patients with juxtarenal abdominal aortic aneurysms scheduled for open surgery
- Patients with juxtarenal abdominal aortic aneurysms, which require suprarenal aortic cross clamping
- Patients with juxtarenal abdominal aortic aneurysms, which are of atheromatous etiology or which developed after aortic dissection
- Affiliation with, or beneficiary of a Social security (national health insurance) scheme
Key exclusion criteria (12 listed)
- Patients dependent from dialysis
- Patients with aortic aneurysms, which require reconstruction of the visceral arteries
- Patients with aortic aneurysms, which require supra-visceral aortic cross clamping
- Patients with wall thrombus or calcification of inter- and suprarenal aorta
- Patients with septic aortitis
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 |
|---|---|---|
| patients with aortic clamping with preconditioningExperimental group (arm 1) consists of patients receiving open juxtarenal aortic aneurysm surgery with direct preconditioning by clamping the suprarenal aorta, which starts after randomization. The procedure for IPC will be achieved by two cycles of supra-renal aortic cross clamping during 5 minutes followed by an unclamping period of 5 minutes before starting the supra-renal aortic cross clamping needed to perform surgery. The level of aortic cross clamping used for IPC will be that required for aortic repair. | Procedure or surgery | Arm 1 - Experimental group: |
| patients with aortic clamping without preconditioningControl group (arm 2) consists of patients receiving open juxtarenal aortic aneurysm surgery without preconditionning | Procedure or surgery | Arm 2 - Control group: |
Primary outcome
To demonstrate the efficacy of ischemic preconditioning (IPC) applied closely to the supra-renal aorta with respect to the occurrence of Acute Kidney Injury (AKI) among patients undergoing open juxtarenal aortic aneurysm surgery.
Time frame: Day 8
The primary endpoint is the occurrence of a postoperative AKI of stage > 1 before the morning visit on day 8. We use the KDIGO work group's definition of AKI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for Aneurysm Aortic
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients with aortic clamping with preconditioning and patients with aortic clamping without preconditioning in people with Aneurysm Aortic, run by University Hospital, Rouen at 7 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didier PLISSONNIER, MD, PHD (02 32 88 66 31 ext. +33, didier.plissonnier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the efficacy of ischemic preconditioning (IPC) applied closely to the supra-renal aorta with respect to the occurrence of Acute Kidney Injury (AKI) among patients undergoing open juxtarenal aortic aneurysm surgery. (time frame: Day 8). 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 9 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.