TY  - BOOK
AU  - Lipinski, Michael J
TI  - A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design
SN  - 0002-8703
PY  - 2016///
KW  - *Cardiac Output, Low/th [Therapy]
KW  - *Cardiotonic Agents/tu [Therapeutic Use]
KW  - *Hydrazones/tu [Therapeutic Use]
KW  - *Intra-Aortic Balloon Pumping
KW  - *Postoperative Complications/th [Therapy]
KW  - *Pyridazines/tu [Therapeutic Use]
KW  - Acute Kidney Injury/ep [Epidemiology]
KW  - Cardiac Output, Low/mo [Mortality]
KW  - Cardiac Surgical Procedures/mo [Mortality]
KW  - Double-Blind Method
KW  - Humans
KW  - Infusions, Intravenous
KW  - Intensive Care Units
KW  - Length of Stay/sn [Statistics & Numerical Data]
KW  - Postoperative Complications/mo [Mortality]
KW  - Respiration, Artificial
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
N2  - 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
UR  - https://dx.doi.org/10.1016/j.ahj.2016.03.021
ER  -