In patients with acute failure of kidney function, levosimendan will be given to help attenuate the course of kdiney failure and aid patients to recover faster.

Phase 1

Conditions: Acute Kidney Injury (AKI) in adult ICU patients
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2012-004979-39-NL

Lead Sponsor: VieCuri Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate the effect of levosimendan, a novel calcium sensitizer with inotropic, anti-inflammatory, anti-apoptotic and anti-oxidative effects, on renal function in an heterogenous ICU-population with Acute Kidney Injury (stage > Injury according to the RIFLE criteria). ;Secondary Objective: Study the effects of levosimendan on renal (filtration) function, mortality and urine output.;Primary end point(s): The aim of the present study is to evaluate whether the clinical use of levosimendan in a heterogeneous study population of ICU patients with early AKI according to AKI-biomarker Neutrophil Gelatinase-Associated Lipocaline (NGAL) is able to improve kidney function expressed by an improved endogenous creatinine clearance of 10 mL/min within 72 hours.;Timepoint(s) of evaluation of this end point: Renal function will be assessed at the start of levosimendan-administration and after 24, 48 and 72 hours.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objectives are:<br>* To evaluate the effect of levosimendan on renal oxygen extraction, defined as the difference between renal venous oxygen saturation and arterial oxygen saturation. <br>* To evaluate the effect of levosimendan on the urinary NGAL-levels, eGFR and urinary output<br>* To evalute the effect of levosimendan on cardiac output and contractility<br>* To assess the need for renal replacement therapy (RRT)<br>* To assess mortality in both groups at 28- and 45 days.;Timepoint(s) of evaluation of this end point: see E5.1.1