Levosimendan in Acute Kidney Injury Study
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in renal function
time frame: Baseline and every 24 hours until end ICU stay
Male or female participants at least 18 years old.
- Clinically diagnosed adult patients with AKI
- 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
- 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
|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.|
Call for more information