title: A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII.
abstract: OBJECTIVE
  This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery.
  
  
  METHODS
  A double-blind, placebo-controlled, randomised trial.
  
  
  METHODS
  A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension.
  
  
  CONCLUSIONS
  This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters.
authors.affiliation: Department of Anesthesiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: E J
authors.initials: EJ
authors.lastname: Bakker
authors.forename: N J
authors.initials: NJ
authors.lastname: Ravensbergen
authors.forename: M T
authors.initials: MT
authors.lastname: Voute
authors.forename: S E
authors.initials: SE
authors.lastname: Hoeks
authors.forename: M
authors.initials: M
authors.lastname: Chonchol
authors.forename: M
authors.initials: M
authors.lastname: Klimek
authors.forename: D
authors.initials: D
authors.lastname: Poldermans
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage*; D000328:Adult; D004311:Double-Blind Method; D006339:Heart Rate / Q000187:drug effects*; D006439:Hemodynamics; D006801:Humans; D007262:Infusions, Intravenous; D007511:Ischemia / Q000517:prevention & control*; D008790:Metoprolol / Q000008:administration & dosage / Q000031:analogs & derivatives; D059035:Perioperative Period; D011412:Propanolamines / Q000008:administration & dosage*; D012107:Research Design; D014656:Vascular Surgical Procedures
chemical_list: D000319:Adrenergic beta-Antagonists; D011412:Propanolamines; D008790:Metoprolol; C036604:esmolol