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

Not Applicable

Completed

• Conditions: Aortic Aneurysm; Surgery
• Interventions: Procedure: clamping with pre-conditioning (PCl)

• Registration Number: NCT03718312
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-07-29
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Patient > 18 and <85 years old
2. Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
3. Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
4. Aortic aneurysmal patient with or without distal femoral circulatory assistance,
5. Patient with aortic aneurysm of atheromatous or dissecting etiology,
6. 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)
7. Patient who read and understood the newsletter and signed the consent form
8. Patient affiliated with a social security scheme

Exclusion Criteria

1. Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),
2. Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)
3. Patient requiring emergency aortic surgery
4. Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),
5. Pregnant or lactating woman (negative result of baseline blood test)
6. Participation in another interventional study within 28 days before randomization or during this study
7. Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults,
8. Patient under the protection of justice, patient under guardianship or curatorship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	clamping with pre-conditioning (PCl)	Patients with aortic clamping withpre-conditioning

Primary Outcome Measures

Name	Time	Method
occurrence of a kidney complication	During the 8 days after surgery	According to RIFLE criteria
occurrence of a pulmonary complication	During the 48 hours after initial extubation	Need for a new ventilation (invasive or not)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital, Rouen; 🇫🇷 Rouen, France