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Levosimendan in Acute Kidney Injury Study (LAKIS)

This study is not yet open for participant recruitment.
Verified October 2012 by VieCuri Medical Centre
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Dr. Jos le Noble, VieCuri Medical Centre
ClinicalTrials.gov Identifier:
NCT01720030
First received: October 3, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 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: Safety and Efficacy of Levosimendan Administration to Optimize Renal Function in Adult 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 by measurement of RIFLE score

  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Survival of included AKI patients in our ICU measured at day 28


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed patients with AKI

Exclusion Criteria:

  • Moribund patients neutropenic patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720030

Locations
Netherlands
VieCuri Medical Center Not yet recruiting
Venlo, Limburg, Netherlands, NL-5912 BL
Contact: Jos le Noble, MD, Ph.D     +31 (0)77-3205785     jlenoble@viecuri.nl    
Sponsors and Collaborators
VieCuri Medical Centre
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Jos Le Noble, MD PhD VieCuri Medical Centre
  More Information

No publications provided

Responsible Party: Dr. Jos le Noble, PhD, MD, VieCuri Medical Centre
ClinicalTrials.gov Identifier: NCT01720030     History of Changes
Other Study ID Numbers: Levosimendan in AKI Study
Study First Received: October 3, 2012
Last Updated: October 30, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VieCuri Medical Centre:
Renal
Acute Kidney Injury
AKI
Levosimendan
 Simdax
Renal perfusion
Mortality
Renal flow

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013