Levosimendan in Acute Kidney Injury Study (LAKIS)

September 26, 2016 updated by: Dr. Jos le Noble, VieCuri Medical Centre

Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Venlo, Limburg, Netherlands, NL-5912 BL
        • Viecuri Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Conventional therapy
Standard of care as protocolized locally
Drug: Conventional therapy
Placebo therapy to safeguard blinding
Other Names:
  • 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 Names:
  • Simdax (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and every 24 hours until end ICU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VieCuri Medical Centre

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Jos Le Noble, MD PhD, Viecuri Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (ESTIMATE)

November 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levosimendan in AKI Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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