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Levosimendan in Acute Kidney Injury Study (LAKIS)

This study is ongoing, but not recruiting participants.
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Dr. Jos le Noble, VieCuri Medical Centre Identifier:
First received: October 3, 2012
Last updated: September 26, 2016
Last verified: September 2016
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

Condition Intervention Phase
Acute Kidney Injury
Drug: Levosimendan
Drug: Conventional therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by VieCuri Medical Centre:

Primary Outcome Measures:
  • Change in renal function [ Time Frame: Baseline and every 24 hours until end ICU stay ] [ Designated as safety issue: No ]
    Daily analysis of kidney function expressed in endogenous creatinine clearance

Enrollment: 68
Study Start Date: September 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Conventional therapy
Standard of care as protocolized locally
Drug: Conventional therapy
Placebo therapy to safeguard blinding
Other Name: Standard care plus placebo comparator
Experimental: 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.
Drug: Levosimendan
Verum therapy
Other Name: Simdax (R)

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01720030

VieCuri Medical Center
Venlo, Limburg, Netherlands, NL-5912 BL
Sponsors and Collaborators
VieCuri Medical Centre
Orion Corporation, Orion Pharma
Principal Investigator: Jos Le Noble, MD PhD VieCuri Medical Centre
  More Information

Responsible Party: Dr. Jos le Noble, PhD, MD, VieCuri Medical Centre Identifier: NCT01720030     History of Changes
Other Study ID Numbers: Levosimendan in AKI Study 
Study First Received: October 3, 2012
Last Updated: September 26, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VieCuri Medical Centre:
Acute Kidney Injury
Renal perfusion
Renal flow

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs processed this record on October 27, 2016