Study Stopped
recruitment difficulties
Effects of Ischemic Preconditioning After Aortic Clamping
Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
1 other identifier
interventional
59
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedApril 27, 2022
April 1, 2022
3.1 years
June 26, 2014
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Renal damage
Day 0, day 1, day 3 or day 5.
Muscle weakness
Day 0, day 1, day 3 or day 5
Myocardial damage measured by troponin level > 0.4 microgr/L
Day 0, 3, or 5
Study Arms (2)
Ischemic preconditioning arm
EXPERIMENTALPatients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.
Control patients
OTHERUsual surgery assigned to control patients
Interventions
Ischemic preconditioning during aortic clamping
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients under guardianship
- No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
- Pregnancy, lactation
- Hemodialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service de Chirurgie Vasculaire, CH Jean Minjoz
Besançon, 25030, France
Service de Chirurgie Vasculaire, CHU le Bocage
Dijon, 21079, France
Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy
Vantoux, 57070, France
Related Publications (1)
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PMID: 36645250DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Lejay, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2014
First Posted
October 2, 2014
Study Start
November 20, 2018
Primary Completion
December 15, 2021
Study Completion
December 15, 2021
Last Updated
April 27, 2022
Record last verified: 2022-04