Levosimendan in Acute Kidney Injury Study (LAKIS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 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 7, 2013
Last verified: October 2013
  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 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

  • 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 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 7, 2013
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
Wounds and Injuries
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 August 18, 2014