Aneurysm Aortic
Conditions
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.
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
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prognostic, prospective, comparative, randomized, open, multi-centre, national study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
France
Contacts
CONTACTDidier PLISSONNIER, MD, PHD
Outcome results
None listed