Effects of Ischemic Preconditioning After Aortic Clamping

Not Applicable

Terminated

• Conditions: Ischemia Preconditioning; Ischemia-reperfusion; Vascular Surgery
• Interventions: Procedure: Ischemic preconditioning during aortic clamping

• Registration Number: NCT02254642
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Study Start: 2018-11-20
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ischemic preconditioning arm	Ischemic preconditioning during aortic clamping	Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.

Primary Outcome Measures

Name	Time	Method
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)	Day 1	Myocardial damage measured by Troponin I level \> 0.4 microg/L

Secondary Outcome Measures

Name	Time	Method
Renal damage	Day 0, day 1, day 3 or day 5.	Renal damage measured with Post-operative Creatinin clearance \< 50% of Pre-operative creatinin clearance
Muscle weakness	Day 0, day 1, day 3 or day 5	Muscle weakness measured by Creatine phospho Kinase \> 200 UI/L
Myocardial damage measured by troponin level > 0.4 microgr/L	Day 0, 3, or 5

Trial Locations

Locations (4)

Service de Chirurgie Vasculaire, CH Jean Minjoz; 🇫🇷 Besancon, France

Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy; 🇫🇷 Vantoux, France

Service de Chirurgie Vasculaire, CHU le Bocage; 🇫🇷 Dijon, France