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ClinicalTrials.gov ID

NCT07441564

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

206Estimated

Last Update Posted

Jun 9, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Dec 1, 2029Estimated

Completion Date

Dec 1, 2029Estimated

Official Title

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

Brief 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.

• Aneurysm Aortic

• patients with aortic clamping with preconditioning
• patients with aortic clamping without preconditioning

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, RouenOTHER

Jonathan.SOBOCINSKI@chu-lille.fr03 20 44 59 62

s.malikov@chru-nancy.fr03 83 15 30 64

blandine.maurel@chu-nantes.fr02 40 16 50 93

laurent.chiche@aphp.fr01 42 17 57 07

didier.plissonnier@chu-rouen.fr02 32 88 66 31

chaufour.x@chu-toulouse.fr05 61 32 39 10