This trial is active, not recruiting.

Condition acute kidney injury
Treatments levosimendan, conventional therapy
Phase phase 2/phase 3
Sponsor VieCuri Medical Centre
Collaborator Orion Corporation, Orion Pharma
Start date September 2016
End date October 2017
Trial size 68 participants
Trial identifier NCT01720030, Levosimendan in AKI Study


We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Standard of care as protocolized locally
conventional therapy Standard care plus placebo comparator
Placebo therapy to safeguard blinding
The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
levosimendan Simdax (R)
Verum therapy

Primary Outcomes

Change in renal function
time frame: Baseline and every 24 hours until end ICU stay

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinically diagnosed adult patients with AKI 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 suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values) - Renal replacement therapy initiated before admission due to Chronic Kidney Disease - Hypersensitivity to levosimendan experienced by previous treatments - Severe hypotension and tachycardia - Significant mechanical obstruction affecting ventricular filling or outflow or both. - Severe hepatic impairment (ALAT/ASAT>400U/L) - Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons - Known history of Torsades de Pointes

Additional Information

Official title Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury
Principal investigator Jos Le Noble, MD PhD
Description The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VieCuri Medical Centre.