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

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.

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Key information

Conditions

Aneurysm Aortic Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de DIJON, Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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 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

Treatment and study plan

patients with aortic clamping with preconditioning

Procedure

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 preconditioning

Procedure

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

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Didier PLISSONNIER, MD, PHD

CONTACT

[email protected]

02 32 88 66 31 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EPAKI

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Mar 2, 2026
Registry last updated: Jun 9, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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