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Levosimendan in Acute Kidney Injury Study (LAKIS)

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Levosimendan
Conventional therapy
Sponsored by
VieCuri Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Renal, Acute Kidney Injury, AKI, Levosimendan, Simdax, Renal perfusion, Mortality, Renal flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VieCuri Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Conventional therapy

Levosimendan

Arm Description

Standard of care as protocolized locally

The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.

Outcomes

Primary Outcome Measures

Change in renal function
Daily analysis of kidney function expressed in endogenous creatinine clearance

Secondary Outcome Measures

Full Information

First Posted
October 3, 2012
Last Updated
September 26, 2016
Sponsor
VieCuri Medical Centre
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01720030
Brief Title
Levosimendan in Acute Kidney Injury Study
Acronym
LAKIS
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VieCuri Medical Centre
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.
Detailed Description
The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Renal, Acute Kidney Injury, AKI, Levosimendan, Simdax, Renal perfusion, Mortality, Renal flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy
Arm Type
Placebo Comparator
Arm Description
Standard of care as protocolized locally
Arm Title
Levosimendan
Arm Type
Experimental
Arm Description
The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
Simdax (R)
Intervention Description
Verum therapy
Intervention Type
Drug
Intervention Name(s)
Conventional therapy
Other Intervention Name(s)
Standard care plus placebo comparator
Intervention Description
Placebo therapy to safeguard blinding
Primary Outcome Measure Information:
Title
Change in renal function
Description
Daily analysis of kidney function expressed in endogenous creatinine clearance
Time Frame
Baseline and every 24 hours until end ICU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos Le Noble, MD PhD
Organizational Affiliation
VieCuri Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
VieCuri Medical Center
City
Venlo
State/Province
Limburg
ZIP/Postal Code
NL-5912 BL
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Levosimendan in Acute Kidney Injury Study

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