evosimendan in Acute Kidney Injury Study

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 68

Inclusion Criteria

*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)

Exclusion Criteria

*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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate in ICU patients with AKI defined by an increase of NGAL whether<br /><br>Levosimendan can improve kidney function by an improved eCC of 10 ml per minute<br /><br>within 72 hours. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Improvement of renal oxygenation<br /><br>Improvement of eGFR and urine output<br /><br>Evaluate Cardiac Output<br /><br>Evaluation of Cardiac Biomarkers<br /><br>Evaluate indication for renal replacement therapy<br /><br>To assess mortality on day 28</p><br>