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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01808-39 | Other Identifier | RCB n° |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Experimental group: | Experimental | patients with aortic clamping with preconditioning |
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| Arm 2 - Control group: | Other | patients with aortic clamping without preconditioning |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didier PLISSONNIER, MD, PHD | Contact | 02 32 88 66 31 | +33 | didier.plissonnier@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de DIJON | Dijon | 21000 | France |
|
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Prognostic, prospective, comparative, randomized, open, multi-centre, national study
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| patients with aortic clamping without preconditioning | Procedure | Control group (arm 2) consists of patients receiving open juxtarenal aortic aneurysm surgery without preconditionning |
|
| CHU de LILLE | Lille | 59000 | France |
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| CHU de NANCY | Nancy | 54511 | France |
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| CHU de NANTES | Nantes | 44093 | France |
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| Ap-Hp La Pitie | Paris | 75013 | France |
|
| CHU de ROUEN | Rouen | 76031 | France |
|
| CHU de TOULOUSE | Toulouse | 31400 | France |
|
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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