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

Surgery Clinical Trial

— EPICATA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718312
• Other study ID #: 2017/388/HP
• Status: Completed
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: July 29, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 29, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Surgery

Intervention

Procedure:
• clamping with pre-conditioning (PCl)
PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period. PCI procedure is repeated twice.

Locations

Country	Name	City	State
France	University Hospital, Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of a pulmonary complication	Need for prolonged invasive ventilation	Before the 48 hours after the beginning surgery
Primary	occurrence of a kidney complication	According to RIFLE criteria	During the 8 days after surgery
Primary	occurrence of a pulmonary complication	Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)	During the 8 days after surgery
Primary	occurrence of a pulmonary complication	Need for a new ventilation (invasive or not)	During the 48 hours after initial extubation
Secondary	Pulmonary Morbidity	Need of a new ventilation (invasive or not)	During the 21 days after surgery
Secondary	Kidney Morbidity	According to RIFLE criteria	During the 21 days after surgery
Secondary	Cardiac Morbidity	Value of troponin	During the 48 hours after surgery
Secondary	cell and tissue damage	Value of D Lactate	During the 8 days after surgery
Secondary	Death		During 60 days after surgery