Effects of Ischemic Preconditioning After Aortic Clamping

Vascular Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254642
• Other study ID #: 5831
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Preconditioning
• Ischemia-reperfusion
• Vascular Surgery

Intervention

Procedure:
• Ischemic preconditioning during aortic clamping
Ischemic preconditioning during aortic clamping
• Procedure/Surgery: usual surgery
Procedure/Surgery: usual surgery

Locations

Country	Name	City	State
France	Service de Chirurgie Vasculaire, CH Jean Minjoz	Besancon
France	Service de Chirurgie Vasculaire, CHU le Bocage	Dijon
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)	Myocardial damage measured by Troponin I level > 0.4 microg/L	Day 1
Secondary	Renal damage	Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance	Day 0, day 1, day 3 or day 5.
Secondary	Muscle weakness	Muscle weakness measured by Creatine phospho Kinase > 200 UI/L	Day 0, day 1, day 3 or day 5
Secondary	Myocardial damage measured by troponin level > 0.4 microgr/L		Day 0, 3, or 5