Levosimendan in Acute Kidney Injury Study

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

Detailed Description
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The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Official Title
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Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Levosimendan
* Drug: Conventional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional therapy<br>Standard of care as protocolized locally | Drug: Conventional therapy<br>* Placebo therapy to safeguard blinding<br>* Other names: Standard care plus placebo comparator;|
| Experimental: Levosimendan<br>The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI. | Drug: Levosimendan<br>* Verum therapy<br>* Other names: Simdax (R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function | Daily analysis of kidney function expressed in endogenous creatinine clearance | Baseline and every 24 hours until end ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simdax, Renal, Acute Kidney Injury, AKI, Levosimendan, Renal perfusion, Mortality, Renal flow