Effects of Ischemic Preconditioning After Aortic Clamping

April 19, 2022 updated by: University Hospital, Strasbourg, France

Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • Service de Chirurgie Vasculaire, CH Jean Minjoz
      • Dijon, France, 21079
        • Service de Chirurgie Vasculaire, CHU le Bocage
      • Strasbourg, France, 67091
        • Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
      • Vantoux, France, 57070
        • Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0, day 1, day 3 or day 5.
Muscle weakness
Time Frame: Day 0, day 1, day 3 or day 5
Muscle weakness measured by Creatine phospho Kinase > 200 UI/L
Day 0, day 1, day 3 or day 5
Myocardial damage measured by troponin level > 0.4 microgr/L
Time Frame: Day 0, 3, or 5
Day 0, 3, or 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Anne Lejay, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5831

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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