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临床试验/NCT04917497
NCT04917497已完成不适用

Levosimendan Infusion in Critically Ill Patients With Cardiogenic Shock

University of Zurich0 个研究点目标入组 43 人开始时间: 2011年6月30日最近更新:
适应症
干预措施
相关药物

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

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

研究者

申办方类型
Other
责任方
Sponsor

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