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临床试验/NL-OMON43813
NL-OMON43813撤回3 期

evosimendan in Acute Kidney Injury Study - LAKIS

Viecuri Medisch Centrum voor Noord-Limburg0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
撤回
发起方
入组人数
68

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • *Over age of 18
  • *Informed consent is received
  • *Admitted to ICU
  • *Receiving diagnosis AKI with RIFLE criteria risk score *Injury (I) ***
  • (***For diagnosis of AKI, an previous serum creatinine value has to be available in the electronic patient record. However, creatinine is known for its fluctuations, mainly in critically ill patients. Therefore, for diagnosis of AKI, the serum creatinine at moment of possible inclusion in our trial will be compared to a previous value which is a maximum of 14 days old)

排除标准

  • *Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
  • *Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs
  • *Moribund patients
  • *Patients under the age of 18
  • *Pregnancy
  • *Patients with mono kidney or just one functional kidney (i.e: contracted kidneys)
  • *Patients with post renal obstruction of any cause
  • *Renal replacement therapy initiated before admission due to Chronic Kidney Disease or predialysis
  • *Hypersensitity to levosimendan experienced by previous treatments
  • *Severe hypotension (MAP<60mmHg) and/or tachycardia (>180bpm) despite measures
  • *Significant pre-existing mechanical obstruction affecting ventricular filling or outflow or both
  • (*** Mechanical obstruction is defined as an *mild* or * moderate* in severity, as judged by the cardiologist performing previous echocardiogram)
  • *Severe hepatic impairment (ALAT/ASAT>400U/L)
  • *Patients will be excluded if the treating physician judges that study participation is undesirable due to an assumed short life expectancy
  • *Known history of Torsades de Pointes

研究者

发起方
Viecuri Medisch Centrum voor Noord-Limburg

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