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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)

Primary Purpose

Aortic Aneurysm, Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
clamping with pre-conditioning (PCl)
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Aneurysm focused on measuring Clamping, pre-conditioning

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital, Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

Patients with aortic clamping withpre-conditioning

Patients with aortic clamping without pre-conditioning

Outcomes

Primary Outcome Measures

occurrence of a pulmonary complication
Need for prolonged invasive ventilation
occurrence of a kidney complication
According to RIFLE criteria
occurrence of a pulmonary complication
Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)
occurrence of a pulmonary complication
Need for a new ventilation (invasive or not)

Secondary Outcome Measures

Pulmonary Morbidity
Need of a new ventilation (invasive or not)
Kidney Morbidity
According to RIFLE criteria
Cardiac Morbidity
Value of troponin
cell and tissue damage
Value of D Lactate
Death

Full Information

First Posted
October 23, 2018
Last Updated
September 14, 2023
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT03718312
Brief Title
Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
Acronym
EPICATA
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
July 11, 2023 (Actual)
Study Completion Date
July 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Surgery
Keywords
Clamping, pre-conditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients with aortic clamping withpre-conditioning
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
Patients with aortic clamping without pre-conditioning
Intervention Type
Procedure
Intervention Name(s)
clamping with pre-conditioning (PCl)
Intervention Description
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 Outcome Measure Information:
Title
occurrence of a pulmonary complication
Description
Need for prolonged invasive ventilation
Time Frame
Before the 48 hours after the beginning surgery
Title
occurrence of a kidney complication
Description
According to RIFLE criteria
Time Frame
During the 8 days after surgery
Title
occurrence of a pulmonary complication
Description
Occurrence of a moderate or severe acute respiratory distress syndrome (Berlin definition)
Time Frame
During the 8 days after surgery
Title
occurrence of a pulmonary complication
Description
Need for a new ventilation (invasive or not)
Time Frame
During the 48 hours after initial extubation
Secondary Outcome Measure Information:
Title
Pulmonary Morbidity
Description
Need of a new ventilation (invasive or not)
Time Frame
During the 21 days after surgery
Title
Kidney Morbidity
Description
According to RIFLE criteria
Time Frame
During the 21 days after surgery
Title
Cardiac Morbidity
Description
Value of troponin
Time Frame
During the 48 hours after surgery
Title
cell and tissue damage
Description
Value of D Lactate
Time Frame
During the 8 days after surgery
Title
Death
Time Frame
During 60 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital, Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32854681
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.
Results Reference
derived

Learn more about this trial

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

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