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.
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.; Situm, 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.. - In: SIGNA VITAE. - ISSN 1334-5605. - 20:12(2024), pp. 1-9. [10.22514/sv.2024.151]
Remote ischemic preconditioning in non-cardiac surgery (PRINCE): a multinational, double blind, sham-controlled, randomized clinical trial
Lombardi G.;Russo A.;Pieri M.;Landoni G.;Zangrillo A.;
2024-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.