NCT03230136

Protection During Cardiac Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

Conditions

• Thoracic Surgery
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
OTHER	multimodal cardioprotection strategy	Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).
OTHER	standard anesthetic procedure	standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.

Timeline

• Start date: 2018-01-03
• Primary completion: 2019-05-30
• Completion: 2019-07-03
• First posted: 2017-07-26
• Last updated: 2025-12-19

Locations

8 sites across 1 country: France