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OpenTrials
Completed

NCT Number: NCT03718312

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. occurrence of a pulmonary complication

    Time frame: Before the 48 hours after the beginning surgery

    Need for prolonged invasive ventilation

  2. occurrence of a kidney complication

    Time frame: During the 8 days after surgery

    According to RIFLE criteria

  3. occurrence of a pulmonary complication

    Time frame: During the 8 days after surgery

    Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)

  4. occurrence of a pulmonary complication

    Time frame: During the 48 hours after initial extubation

    Need for a new ventilation (invasive or not)

Secondary outcomes

  1. Pulmonary Morbidity

    Time frame: During the 21 days after surgery

    Need of a new ventilation (invasive or not)

  2. Kidney Morbidity

    Time frame: During the 21 days after surgery

    According to RIFLE criteria

  3. Cardiac Morbidity

    Time frame: During the 48 hours after surgery

    Value of troponin

  4. cell and tissue damage

    Time frame: During the 8 days after surgery

    Value of D Lactate

  5. Death

    Time frame: During 60 days after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EPICATA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2018
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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