ClinicalTrials.gg
Not yet recruitingNCT07441564EPAKIUpdated Jun 9, 2026

Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Juxtarenal Abdominal Aortic Aneurysm

An interventional study of patients with aortic clamping with preconditioning and patients with aortic clamping without preconditioning in Aneurysm Aortic, sponsored by University Hospital, Rouen. Not yet recruiting at 7 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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%. 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.

02

Conditions studied

  • Aneurysm Aortic

Browse trials for

03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 206 is above the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Women of with effective 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)
  • women: confirmation of non-medically induced amenorrhea since at least 12 months prior to the inclusion visit

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
206 participants (estimated)

Study arms

  • Experimental
    Arm 1 - Experimental group:

    patients with aortic clamping with preconditioning

    Procedure: patients with aortic clamping with preconditioning

  • Other
    Arm 2 - Control group:

    patients with aortic clamping without preconditioning

    Procedure: patients with aortic clamping without preconditioning

Interventions

  • Procedurepatients with aortic clamping with preconditioning

    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.

  • Procedurepatients with aortic clamping without preconditioning

    Control group (arm 2) consists of patients receiving open juxtarenal aortic aneurysm surgery without preconditionning

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 8

07

Study locations

7 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07441564
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jun 9, 2026

Study contacts

Didier PLISSONNIER, MD, PHD
Contact
didier.plissonnier@chu-rouen.fr
02 32 88 66 31 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion