Levosimendan Infusion in Critically Ill Patients With Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Change in Fluid Balance
研究概览
简要总结
To determine whether Levosimendan infusion in patients with cardiogenic shock and cardiorenal syndrome refractory to standard inotropic therapy, improves hemodynamics and renal function, whilst being safe.
详细描述
Cardiogenic Shock or the state of systemic hypoxia albeit initially preserved intra-vascular volume and intact vascular function, is solely the result of insufficient cardiac output [1-2]. The ensuing centralization and redistribution of blood-volume, is induced by a stimulation of the renin-angiotensin system, as well as vasopressin and endogenous catecholamine liberation [2-3]. Precipitating Cardiogenic Shock has a direct effect on the kidney, also called the cardiorenal syndrome [4].
The overall consensus for the therapy of cardiogenic shock is the use of inotropes to increase cardiac output and reverse organ hypoxia [2], nevertheless their increase of myocardial and glomerular oxygen consumption make them a double edged sword to use in cardiogenic shock and more prominently in cardiogenic shock coupled with pronounced cardiorenal syndrome.
Levosimendan is an inotropic agent that was developed for the treatment of severely decompensated heart failure. It exerts its inotropic effects primarily through sensitizing Troponin C to calcium and thereby increasing contraction of cardiac myofilaments during systole [5]. Unlike other inotropic agents, Levosimendan acts independently of the beta adrenergic receptor [5]. Additionally, the effect of Levosimendan could be beneficial for the kidneys function by decreasing pre-glomerular arteriolar vasotonus whilst keeping post-glomerular arteriolar vasotonus constant [6].
In light of the scarce but promising literature the question arises if Levosimendan can safely ameliorate cardiac and renal function concomitantly in patients presenting the combination of cardiogenic shock and cardiorenal syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Levosimendan
- •Cardiogenic Shock
- •Continuous monitoring of cardiac output at the start of and during treatment with Levosimendan
排除标准
- •Extracorporal hemodynamic support or an implanted ventricular assist device
- •Previous therapy with Levosimendan during the index hospitalization
- •Refusal of participation in the study
研究组 & 干预措施
Levosimendan Treated Group
All patients consecutively admitted to the medical ICU of the University Hospital Zurich aged over 18 years, with an underlying cardiogenic shock, receiving Levosimendan.
干预措施: Levosimendan (Drug)
结局指标
主要结局
Change in Fluid Balance
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of Fluid Balance post Levosimendan Infusion up until 120 hours
Change in Cardiac Index
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of Cardiac Index post Levosimendan Infusion up until 120 hours
Change in Mean Arterial Pressure
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of Mean Arterial Pressure post Levosimendan Infusion up until 120 hours
Change in Vasoactive/ Inotropic Dosage
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of Norepinephrine/ Dobuatmine Dosage post Levosimendan Infusion up until 120 hours
Change in Cardiac Preload Pressures
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of Wedge Pressure/ Central Venous Pressure post Levosimendan Infusion up until 120 hours
Change in Renal Function
时间窗: Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion
Temporal development of eGFR (Creatinin estimated) post Levosimendan Infusion up until 120 hours
次要结局
未报告次要终点
