A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.
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
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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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