A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.
A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.
- 2016
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
0002-8703
*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, Artificial
MedStar Heart & Vascular Institute
Journal Article
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
0002-8703
*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, Artificial
MedStar Heart & Vascular Institute
Journal Article