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Completed

NCT Number: NCT01720030

Levosimendan in Acute Kidney Injury Study

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

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VieCuri Medical Center

Venlo, Limburg, NL-5912 BL, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levosimendan

Drug

Verum therapy

Other names: Simdax (R)

Conventional therapy

Drug

Placebo therapy to safeguard blinding

Other names: Standard care plus placebo comparator

Primary outcomes

  1. Change in renal function

    Time frame: Baseline and every 24 hours until end ICU stay

    Daily analysis of kidney function expressed in endogenous creatinine clearance

Sponsors and collaborators

Lead sponsor

VieCuri Medical Centre

Other

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study 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

Acronym: LAKIS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2012
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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