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Trial record 1 of 1 for:    03718312
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Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms. (EPICATA)

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ClinicalTrials.gov Identifier: NCT03718312
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Surgery Procedure: clamping with pre-conditioning (PCl) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Patients with aortic clamping withpre-conditioning
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.


No Intervention: Arm 2
Patients with aortic clamping without pre-conditioning



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03718312    
Other Study ID Numbers: 2017/388/HP
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
Clamping
pre-conditioning
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases