Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study.

Patrick Meybohm, Kai Zacharowski, Jochen Cremer, Jan Roesner, Frank Kletzin, Gereon Schaelte, Marc Felzen, Ulrich Strouhal, Christian Reyher, Matthias Heringlake, Julika Schön, Ivo Brandes, Martin Bauer, Pascal Knuefermann, Maria Wittmann, Thomas Hachenberg, Thomas Schilling, Thorsten Smul, Sonja Maisch, Michael SanderTobias Moormann, Andreas Boening, Markus A Weigand, Rita Laufenberg, Christian Werner, Michael Winterhalter, Tanja Treschan, Sebastian N Stehr, Konrad Reinhart, Dirk Hasenclever, Oana Brosteanu, Berthold Bein

Abstract

Aims: Transient ischaemia of non-vital tissue has been shown to enhance the tolerance of remote organs to cope with a subsequent prolonged ischaemic event in a number of clinical conditions, a phenomenon known as remote ischaemic preconditioning (RIPC). However, there remains uncertainty about the efficacy of RIPC in patients undergoing cardiac surgery. The purpose of this report is to describe the design and methods used in the "Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart)-Study".; Methods: We are conducting a prospective, randomized, double-blind, multicentre, controlled trial including 2070 adult cardiac surgical patients. All types of surgery in which cardiopulmonary bypass is used will be included. Patients will be randomized either to the RIPC group receiving four 5 min cycles of transient upper limb ischaemia/reperfusion or to the control group receiving four cycles of blood pressure cuff inflation/deflation at a dummy arm. The primary endpoint is a composite outcome (all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure) until hospital discharge.; Conclusion: The RIPHeart-Study is a multicentre trial to determine whether RIPC may improve clinical outcome in cardiac surgical patients.;
Original languageEnglish
Title of host publicationEuropean Heart Journal
Number of pages4
Place of PublicationClinic of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt am Main, Germany. patrick.meybohm@kgu.de
PublisherOxford University Press
Publication date06.2012
Pages1423-1426
ISBN (Print)1522-9645 (Electronic)\r0195-668X (Linking)
Publication statusPublished - 06.2012

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