Remote ischemic preconditioning in non-cardiac surgery (PRINCE): a multinational, double blind, sham-controlled, randomized clinical trial


Greco M. Lombardi G. Konkayev A. Brusasco C. Lei C. Roasio A. Rana N. Mantilla-Gutierrez H.A. Micali M. Gazivoda G. Gandini M. Ti L.K. Bosso S. Konkayeva M. Meroi F. Wang L. Russo A. Efremov S. Fresta G. Berikashvili L. Livi F. Šitum I. Guarracino F. Leonova E. Cavenago F. Shemetova M. Cristallo E. Smirnova A. Schiavoni L. Subbotin V. Boffa N. Giardina G. Introna M. Nakhnoukh C. Covello R.D. Pieri M. Turi S. Ajello V. Monaco F. Corradi F. Yavorovskiy A. Likhvantsev V. Longhini F. Bove T. Bellomo R. Landoni G. Zangrillo A. Lembo R.
December 2024Pharmamed Mado Ltd

Signa Vitae
2024#20Issue 121 - 9 pp.

Remote ischemic preconditioning (RIPC) is a clinical procedure aimed at inducing myocardial protection by causing brief ischemia-reperfusion episodes in an organ remote from the heart. We aim to assess whether RIPC provides myocardial protection in patients undergoing non-cardiac surgery. This study, called remote ischemic PReconditioning In Non-Cardiac surgEry (PRINCE), is a double-blind, multinational randomized clinical trial (1:1 allocation ratio) which plans to enroll 1100 patients. The intervention arm will receive RIPC at the beginning of surgery by inflating a blood pressure cuff around a limb for three cycles of ten minutes (inflated cuff for five minutes followed by deflated cuff for five minutes). In the control group, a blood pressure cuff will be put on a limb, and a sham inflation will be performed. Given a potential interaction of propofol with RIPC, induction and maintenance of anesthesia will be performed without propofol. The primary endpoint of the study is to document a significant reduction in postoperative cardiac troponin values among patients receiving RIPC. Secondary endpoints will be cardiac ischemic events at 30 days and 1 year, mortality at 30 days and 1 year, neurologic events at 30 days and 1 year, acute kidney injury at 7 days, need for intensive care unit admission and length of hospital stay. The trial will provide evidence for the effects of RIPC on cardioprotection and other relevant outcomes in high-cardiac risk patients undergoing non-cardiac surgery. Clinical Trial Registration: NCT02427867.

Cardioprotection , Non-cardiac surgery , Remote ischemic preconditioning

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Department of Biomedical Sciences, Humanitas University, MI, Pieve Emanuele, 20072, Italy
Department of Anesthesiology and Intensive Care, IRCCS Humanitas Research Hospital, MI, Rozzano, 20089, Italy
Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, 20132, Italy
Astana Medical University, Astana, 010000, Kazakhstan
National Scientific Center of Traumatology and Orthopedia Named N.Batpenov, Astana, 010000, Kazakhstan
Anesthesia and Intensive Care Unit, Galliera Hospital, Genova, 16128, Italy
Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Shaanxi, Xi’an, 710032, China
Department of Anaesthesia and Intensive Care, Cardinal Massaia Hospital, Asti, 14100, Italy
Division of Anaesthesiology, Ospedale Regionale di Lugano, TI, Lugano, 6900, Switzerland
Department of Anesthesiology, Fundación Cardioinfantil-Instituto de Cardiología, Bogotá, 111321, Colombia
Cardiovascular Institute Dedinje, Belgrade, 11040, Serbia
Department of Anaesthesia, National University Hospital, 119074, Singapore
Department of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Central Friuli, Udine, 33100, Italy
Department of Anesthesiology, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Roma, 00168, Italy
Saint-Petersburg State University Hospital, Saint-Petersburg, 190103, Russian Federation
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Moscow, 107031, Russian Federation
Department of Anesthesia and Critical Care, Azienda Ospedaliero-Universitaria Careggi, Florence, 50134, Italy
Department of Anesthesiologyand ICU University Hospital Centre Zagreb, Zagreb, 10000, Croatia
Department of Cardiothoracic and vascular Anaesthesia and Intensive Care, Azienda Ospedaliero Universitaria Pisana, Pisa, 56123, Italy
Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health, Moscow, 117152, Russian Federation
I.M. Sechenov First Moscow State Medical University of the Russian Ministry of Health, Moscow, 119991, Russian Federation
Department of Anesthesia and Intensive Care, Fondazione Policlinico Universitario Campus Bio-Medico, Roma, 00128, Italy
A. Loginov Moscow Clinical Scientific Center, Moscow, 111123, Russian Federation
Department of Anesthesia and Intensive Care, Azienda Ospedaliera San Donà di Piave, Venezia, 30027, Italy
NeuroAnesthesia and NeuroIntensive Care, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, 20133, Italy
Anesthesia and Intensive Care Unit, Emergency Department, Busto Arsizio Hospital, ASST Valle Olona, Varese, 21052, Italy
Department of Cardiothoracic Anesthesia, Tor Vergata University Hospital, Rome, 00100, Italy
Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, 56126, Italy
Anesthesia and Intensive Care, Department of Medical and Surgical Sciences, “Magna Graecia” University, Catanzaro, 88100, Italy
Department of Medicine (DMED), University of Udine, Udine, 33100, Italy
Department of Critical Care, The University of Melbourne, Melbourne, 3010, VIC, Australia
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, 3800, VIC, Australia
School of Medicine, Vita-Salute San Raffaele University, Milan, 20132, Italy

Department of Biomedical Sciences
Department of Anesthesiology and Intensive Care
Department of Anesthesia and Intensive Care
Astana Medical University
National Scientific Center of Traumatology and Orthopedia Named N.Batpenov
Anesthesia and Intensive Care Unit
Department of Anesthesiology and Perioperative Medicine
Department of Anaesthesia and Intensive Care
Division of Anaesthesiology
Department of Anesthesiology
Cardiovascular Institute Dedinje
Department of Anaesthesia
Department of Anesthesia and Intensive Care Medicine
Department of Anesthesiology
Saint-Petersburg State University Hospital
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Department of Anesthesia and Critical Care
Department of Anesthesiologyand ICU University Hospital Centre Zagreb
Department of Cardiothoracic and vascular Anaesthesia and Intensive Care
Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health
I.M. Sechenov First Moscow State Medical University of the Russian Ministry of Health
Department of Anesthesia and Intensive Care
A. Loginov Moscow Clinical Scientific Center
Department of Anesthesia and Intensive Care
NeuroAnesthesia and NeuroIntensive Care
Anesthesia and Intensive Care Unit
Department of Cardiothoracic Anesthesia
Department of Surgical
Anesthesia and Intensive Care
Department of Medicine (DMED)
Department of Critical Care
Australian and New Zealand Intensive Care Research Centre
School of Medicine

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