Protection During Cardiac Surgery.

NCT03230136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-12-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Jean-Luc FELLAHI · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2019-05-30
Completion
2019-07-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230136 on ClinicalTrials.gov