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

NCT03718312 | Completed

• 1 other identifier: 2017/388/HP
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm; Surgery

Keywords

Clamping; pre-conditioning

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Pulmonary Morbidity

  During the 21 days after surgery

• Kidney Morbidity

  During the 21 days after surgery

• Cardiac Morbidity

  During the 48 hours after surgery

• cell and tissue damage

  During the 8 days after surgery

• Death

  During 60 days after surgery

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients with aortic clamping withpre-conditioning

Procedure: clamping with pre-conditioning (PCl)

Arm 2

NO INTERVENTION

Patients with aortic clamping without pre-conditioning

Interventions

clamping with pre-conditioning (PCl) PROCEDURE

PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period. PCI procedure is repeated twice.

Arm 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital, Rouen

Rouen, 76031, France

Location

Related Publications (2)

• Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

  PMID: 36645250 DERIVED

• 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.

  PMID: 32854681 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Constriction

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: July 29, 2019
• Primary Completion: July 11, 2023
• Study Completion: July 29, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

FR (1)