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Levosimendan in Acute Kidney Injury Study (LAKIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720030
Recruitment Status : Unknown
Verified September 2016 by Dr. Jos le Noble, VieCuri Medical Centre.
Recruitment status was:  Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : September 27, 2016
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Dr. Jos le Noble, VieCuri Medical Centre

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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Levosimendan Drug: Conventional therapy Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
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)

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720030

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

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Responsible Party: Dr. Jos le Noble, PhD, MD, VieCuri Medical Centre Identifier: NCT01720030     History of Changes
Other Study ID Numbers: Levosimendan in AKI Study
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Dr. Jos le Noble, VieCuri Medical Centre:
Acute Kidney Injury
Renal perfusion
Renal flow

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs