Levosimendan in Acute Kidney Injury Study (LAKIS)

VieCuri Medical Centre

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Kidney Injury

Treatments: Drug: Conventional therapy; Drug: Levosimendan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01720030

Levosimendan in AKI Study

Details and patient eligibility

About

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

Full description

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Conventional therapy

Placebo Comparator group

Description:

Standard of care as protocolized locally

Treatment:

Drug: Conventional therapy

Levosimendan

Experimental group

Description:

The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.

Treatment:

Drug: Levosimendan