Clinical trial NCT03718312: Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
Official title: Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Surgery
Keywords: Clamping
pre-conditioning
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: occurrence of a pulmonary complication
timeFrame: Before the 48 hours after the beginning surgery
measure: occurrence of a kidney complication
timeFrame: During the 8 days after surgery
measure: occurrence of a pulmonary complication
timeFrame: During the 8 days after surgery
measure: occurrence of a pulmonary complication
timeFrame: During the 48 hours after initial extubation
Secondary outcomes:
measure: Pulmonary Morbidity
timeFrame: During the 21 days after surgery
measure: Kidney Morbidity
timeFrame: During the 21 days after surgery
measure: Cardiac Morbidity
timeFrame: During the 48 hours after surgery
measure: cell and tissue damage
timeFrame: During the 8 days after surgery
measure: Death
timeFrame: During 60 days after surgery
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital, Rouen
Study officials:
References:
citation: Palmier M, Bubenheim M, Chiche L, Chaufour X, Koskas F, Fadel E, Magnan PE, Ducasse E, Chakfe N, Steinmetz E, Dusseaux MM, Ricco JB, Plissonnier D. Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery). BMC Surg. 2020 Aug 27;20(1):193. doi: 10.1186/s12893-020-00851-3.