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

February 23, 2026 updated by: University Hospital, Rouen
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Experimental group:
patients with aortic clamping with preconditioning
Procedure: patients 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.
Other: Arm 2 - Control group:
patients with aortic clamping without preconditioning
Procedure: patients with aortic clamping without preconditioning
Control group (arm 2) consists of patients receiving open juxtarenal aortic aneurysm surgery without preconditionning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0298/HP
  • 2024-A01808-39 (Other Identifier: RCB n°)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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