Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Study Overview
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Brief Summary
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Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups: Arm 1 : Patients with aortic clamping with pre-conditioning Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.

Official Title
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Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Conditions
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Surgery, Aortic Aneurysm

Intervention / Treatment
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* Procedure: clamping with pre-conditioning (PCl)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 18 and <85 years old Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach, Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction, Aortic aneurysmal patient with or without distal femoral circulatory assistance, Patient with aortic aneurysm of atheromatous or dissecting etiology, Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy) Patient who read and understood the newsletter and signed the consent form Patient affiliated with a social security scheme Exclusion Criteria: Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta), Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch) Patient requiring emergency aortic surgery Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents), Pregnant or lactating woman (negative result of baseline blood test) Participation in another interventional study within 28 days before randomization or during this study Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults, Patient under the protection of justice, patient under guardianship or curatorship.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients with aortic clamping withpre-conditioning | Procedure: clamping with pre-conditioning (PCl)<br>* PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period. PCI procedure is repeated twice.<br>|
| No Intervention: Arm 2<br>Patients with aortic clamping without pre-conditioning | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of a pulmonary complication | Need for prolonged invasive ventilation | Before the 48 hours after the beginning surgery | 
| occurrence of a kidney complication | According to RIFLE criteria | During the 8 days after surgery | 
| occurrence of a pulmonary complication | Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition) | During the 8 days after surgery | 
| occurrence of a pulmonary complication | Need for a new ventilation (invasive or not) | During the 48 hours after initial extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Morbidity | Need of a new ventilation (invasive or not) | During the 21 days after surgery | 
| Kidney Morbidity | According to RIFLE criteria | During the 21 days after surgery | 
| Cardiac Morbidity | Value of troponin | During the 48 hours after surgery | 
| cell and tissue damage | Value of D Lactate | During the 8 days after surgery | 
| Death |  | During 60 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clamping, pre-conditioning