Levosimendan in Acute Kidney Injury Study
- Registration Number
- NCT01720030
- Lead Sponsor
- VieCuri Medical Centre
- Brief Summary
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.
- Detailed Description
The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- Clinically diagnosed adult patients with AKI
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional therapy Conventional therapy Standard of care as protocolized locally Levosimendan Levosimendan The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
- Primary Outcome Measures
Name Time Method Change in renal function Baseline and every 24 hours until end ICU stay Daily analysis of kidney function expressed in endogenous creatinine clearance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
VieCuri Medical Center
🇳🇱Venlo, Limburg, Netherlands