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Effects of Ischemic Preconditioning After Aortic Clamping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254642
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Vascular Surgery Ischemia-reperfusion Ischemia Preconditioning Procedure: Ischemic preconditioning during aortic clamping Procedure: Procedure/Surgery: usual surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2022

Arm Intervention/treatment
Experimental: Ischemic preconditioning arm
Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.
Procedure: Ischemic preconditioning during aortic clamping
Ischemic preconditioning during aortic clamping

Control patients
Usual surgery assigned to control patients
Procedure: Procedure/Surgery: usual surgery
Procedure/Surgery: usual surgery




Primary Outcome Measures :
  1. Myocardial damage measured by troponin level > 0.4 microgr/L (day 1) [ Time Frame: Day 1 ]
    Myocardial damage measured by Troponin I level > 0.4 microg/L


Secondary Outcome Measures :
  1. Renal damage [ Time Frame: Day 0, day 1, day 3 or day 5. ]
    Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance

  2. Muscle weakness [ Time Frame: Day 0, day 1, day 3 or day 5 ]
    Muscle weakness measured by Creatine phospho Kinase > 200 UI/L

  3. Myocardial damage measured by troponin level > 0.4 microgr/L [ Time Frame: Day 0, 3, or 5 ]


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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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254642


Contacts
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Contact: Anne LEJAY, MD 33.3.69.55.09.07 anne.lejay@chru-strasbourg.fr

Locations
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France
Service de Chirurgie Vasculaire, CH Jean Minjoz Not yet recruiting
Besancon, France, 25030
Contact: Simon RINCKENBACK, MD    33.3.81.66.82.27    srinckenbach@chu-besancon.fr   
Principal Investigator: Simon RINCKENBACH, MD         
Sub-Investigator: Lucie SALOMONT DU MONT, MD         
Service de Chirurgie Vasculaire, CHU le Bocage Not yet recruiting
Dijon, France, 21079
Contact: Eric STEINMETZ, MD    33.3.29.33.52    eric.steinmetz@chu-dijon.fr   
Principal Investigator: Eric STEINMETZ, MD         
Sub-Investigator: Claire FAVIER, MD         
Sub-Investigator: Joaquim DOMINGUEZ, MD         
Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Not yet recruiting
Strasbourg, France, 67091
Contact: Anne Lejay, MD    33.3.69.55.09.07    anne.lejay@chru-strasbourg.fr   
Principal Investigator: Anne Lejay, MD         
Sub-Investigator: Fabien Thaveau, MD         
Sub-Investigator: Nabil CHAKFE, MD         
Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy Recruiting
Vantoux, France, 57070
Contact: Christian MULLER, MD    33.3.57.84.10.10    christian.muller@hp-metz.fr   
Principal Investigator: Christian MULLER, MD         
Sub-Investigator: Fanette JEANNON, MD         
Sub-Investigator: Nicolas FRISCH, MD         
Sub-Investigator: Christophe GRANDCLERE, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Anne Lejay, MD Hôpitaux Universitaires de Strasbourg
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02254642    
Other Study ID Numbers: 5831
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes