Levosimendan in Acute Kidney Injury Study

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01720030

Acronym

LAKIS

Enrollment

Registered

2012-11-01

Start date

2016-09-01

Completion date

2017-10-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Renal, Acute Kidney Injury, AKI, Levosimendan, Simdax, Renal perfusion, Mortality, Renal flow

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.

Interventions

DRUGLevosimendan

Verum therapy

DRUGConventional therapy

Placebo therapy to safeguard blinding

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORJos Le Noble, MD PhD

VieCuri Medical Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026