A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

MedStar author(s):
Citation: American Heart Journal. 177:66-73, 2016 JulPMID: 27297851Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Cardiac Output, Low/th [Therapy] | *Cardiotonic Agents/tu [Therapeutic Use] | *Hydrazones/tu [Therapeutic Use] | *Intra-Aortic Balloon Pumping | *Postoperative Complications/th [Therapy] | *Pyridazines/tu [Therapeutic Use] | Acute Kidney Injury/ep [Epidemiology] | Cardiac Output, Low/mo [Mortality] | Cardiac Surgical Procedures/mo [Mortality] | Double-Blind Method | Humans | Infusions, Intravenous | Intensive Care Units | Length of Stay/sn [Statistics & Numerical Data] | Postoperative Complications/mo [Mortality] | Respiration, ArtificialYear: 2016Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.Copyright � 2016 Elsevier Inc. All rights reserved.DESIGN: Double-blind, placebo-controlled, multicenter randomized trial.INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 mug/[kg min]) or placebo for 24-48 hours.MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.SETTING: Tertiary care hospitals.All authors: Alvaro G, Amantea B, Auci E, Auriemma S, Baiocchi M, Bianchi A, Biondi-Zoccai G, Bove T, Bradic N, Buscaglia G, Calabro MG, Cariello C, Corcione A, De Vuono G, Fominskiy E, Frontini M, Galdieri N, Gemma M, Gianni S, Grigoryev E, Guarracino F, Landoni G, Lembo R, Likhvantsev V, Lipinski MJ, Lobreglio R, Lomivorotov VV, Monaco F, Pala G, Paternoster G, Pisano A, Sangalli F, Wang CY, Zangrillo A, Zucchetti MCFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27297851 Available 27297851

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Copyright � 2016 Elsevier Inc. All rights reserved.

DESIGN: Double-blind, placebo-controlled, multicenter randomized trial.

INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 mug/[kg min]) or placebo for 24-48 hours.

MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.

OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.

SETTING: Tertiary care hospitals.

English

Powered by Koha