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Effects of Ischemic Preconditioning After Aortic Clamping

Primary Purpose

Vascular Surgery, Ischemia-reperfusion, Ischemia Preconditioning

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ischemic preconditioning during aortic clamping
Procedure/Surgery: usual surgery
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Surgery

Eligibility Criteria

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

Inclusion criteria:

  • Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
  • Patients who received clear information, with signed consent
  • Patients 18 to 85 years

Exclusion criteria:

  • Patients under guardianship
  • No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
  • Pregnancy, lactation
  • Hemodialysis

Sites / Locations

  • Service de Chirurgie Vasculaire, CH Jean Minjoz
  • Service de Chirurgie Vasculaire, CHU le Bocage
  • Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ischemic preconditioning arm

Control patients

Arm Description

Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.

Usual surgery assigned to control patients

Outcomes

Primary Outcome Measures

Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
Myocardial damage measured by Troponin I level > 0.4 microg/L

Secondary Outcome Measures

Renal damage
Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance
Muscle weakness
Muscle weakness measured by Creatine phospho Kinase > 200 UI/L
Myocardial damage measured by troponin level > 0.4 microgr/L

Full Information

First Posted
June 26, 2014
Last Updated
April 19, 2022
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02254642
Brief Title
Effects of Ischemic Preconditioning After Aortic Clamping
Official Title
Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

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

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
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Surgery, Ischemia-reperfusion, Ischemia Preconditioning

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ischemic preconditioning arm
Arm Type
Experimental
Arm Description
Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.
Arm Title
Control patients
Arm Type
Other
Arm Description
Usual surgery assigned to control patients
Intervention Type
Procedure
Intervention Name(s)
Ischemic preconditioning during aortic clamping
Intervention Description
Ischemic preconditioning during aortic clamping
Intervention Type
Procedure
Intervention Name(s)
Procedure/Surgery: usual surgery
Intervention Description
Procedure/Surgery: usual surgery
Primary Outcome Measure Information:
Title
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
Description
Myocardial damage measured by Troponin I level > 0.4 microg/L
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Renal damage
Description
Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance
Time Frame
Day 0, day 1, day 3 or day 5.
Title
Muscle weakness
Description
Muscle weakness measured by Creatine phospho Kinase > 200 UI/L
Time Frame
Day 0, day 1, day 3 or day 5
Title
Myocardial damage measured by troponin level > 0.4 microgr/L
Time Frame
Day 0, 3, or 5

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: Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery) Patients who received clear information, with signed consent Patients 18 to 85 years Exclusion criteria: Patients under guardianship No possibility to give the patients clear information (comprehension difficulties, emergency surgery) Pregnancy, lactation Hemodialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Lejay, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Vasculaire, CH Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Chirurgie Vasculaire, CHU le Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy
City
Vantoux
ZIP/Postal Code
57070
Country
France

12. IPD Sharing Statement

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Effects of Ischemic Preconditioning After Aortic Clamping

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