evosimendan in Acute Kidney Injury Study, a prospective, randomized, monocenter, double blind, placebo-controlled study to investigate the efficacy and safety of Levosimendan in Intensive Care Patients with Acute Kidney Injury. - LAKIS

VieCuri Medical Center0 个研究点开始时间: 2014年3月18日最近更新: 2016年10月31日

试验速览

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•The patient
•* Is admitted to the ICU
•* Is > 18 years of age
•* Has received the diagnosis of Acute Kidney Injury with a RIFLE score > I (Injury)
•* Cardiac output > 3.5L/min
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•The patient
•* Is entering the ICU for post-operative observation with an estimated length of stays < 24 hours
•* Is moribund
•* Is pregnant
•* Has a mono-kidney due to any cause of a post-renal obstruction
•* Has been receiving renal replacement therapy due to chronic kidney disease before admission to the ICU
•* Is known with hypersensitivity from previous treatments
•* Has severe hypotension (MAP < 60mmHg) and/or tachycardia (>180/min) despite measures
•* Is known with significant pre-existing mechanical obstruction affecting ventricular filling or outflow.
•* Has severe hepatic impairment (ALAT or ASAT >400U/L)* Is known with torsade des pointes
•Furthermore, the patient will be excluded if treating physician has judged participation in this study as undesirable.

发起方

VieCuri Medical Center