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Effects of Ischemic Preconditioning After Aortic Clamping

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02254642
Enrollment
59
Registered
2014-10-02
Start date
2018-11-20
Completion date
2021-12-15
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia Preconditioning, Ischemia-reperfusion, Vascular Surgery

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.

Interventions

PROCEDUREIschemic preconditioning during aortic clamping

Ischemic preconditioning during aortic clamping

PROCEDUREProcedure/Surgery: usual surgery

Procedure/Surgery: usual surgery

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026