title: Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The RIPHeart-Study is a multicentre trial to determine whether RIPC may improve clinical outcome in cardiac surgical patients.
authors.affiliation: Clinic of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt am Main, Germany. patrick.meybohm@kgu.de
authors.forename: Patrick
authors.initials: P
authors.lastname: Meybohm
authors.forename: Kai
authors.initials: K
authors.lastname: Zacharowski
authors.forename: Jochen
authors.initials: J
authors.lastname: Cremer
authors.forename: Jan
authors.initials: J
authors.lastname: Roesner
authors.forename: Frank
authors.initials: F
authors.lastname: Kletzin
authors.forename: Gereon
authors.initials: G
authors.lastname: Schaelte
authors.forename: Marc
authors.initials: M
authors.lastname: Felzen
authors.forename: Ulrich
authors.initials: U
authors.lastname: Strouhal
authors.forename: Christian
authors.initials: C
authors.lastname: Reyher
authors.forename: Matthias
authors.initials: M
authors.lastname: Heringlake
authors.forename: Julika
authors.initials: J
authors.lastname: Schön
authors.forename: Ivo
authors.initials: I
authors.lastname: Brandes
authors.forename: Martin
authors.initials: M
authors.lastname: Bauer
authors.forename: Pascal
authors.initials: P
authors.lastname: Knuefermann
authors.forename: Maria
authors.initials: M
authors.lastname: Wittmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Hachenberg
authors.forename: Thomas
authors.initials: T
authors.lastname: Schilling
authors.forename: Thorsten
authors.initials: T
authors.lastname: Smul
authors.forename: Sonja
authors.initials: S
authors.lastname: Maisch
authors.forename: Michael
authors.initials: M
authors.lastname: Sander
authors.forename: Tobias
authors.initials: T
authors.lastname: Moormann
authors.forename: Andreas
authors.initials: A
authors.lastname: Boening
authors.forename: Markus A
authors.initials: MA
authors.lastname: Weigand
authors.forename: Rita
authors.initials: R
authors.lastname: Laufenberg
authors.forename: Christian
authors.initials: C
authors.lastname: Werner
authors.forename: Michael
authors.initials: M
authors.lastname: Winterhalter
authors.forename: Tanja
authors.initials: T
authors.lastname: Treschan
authors.forename: Sebastian N
authors.initials: SN
authors.lastname: Stehr
authors.forename: Konrad
authors.initials: K
authors.lastname: Reinhart
authors.forename: Dirk
authors.initials: D
authors.lastname: Hasenclever
authors.forename: Oana
authors.initials: O
authors.lastname: Brosteanu
authors.forename: Berthold
authors.initials: B
authors.lastname: Bein
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000328:Adult; D000368:Aged; D001132:Arm / Q000098:blood supply; D002315:Cardiopulmonary Bypass / Q000379:methods*; D004311:Double-Blind Method; D006801:Humans; D019194:Ischemic Preconditioning / Q000379:methods*; D007866:Leg / Q000098:blood supply; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult