Levosimendan in Acute Kidney Injury Study

Acute Kidney Injury Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01720030
• Other study ID #: Levosimendan in AKI Study
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 3, 2012
• Last updated: September 26, 2016
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: VieCuri Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Drug:
• Levosimendan
Verum therapy
• Conventional therapy
Placebo therapy to safeguard blinding

Locations

Country	Name	City	State
Netherlands	VieCuri Medical Center	Venlo	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
VieCuri Medical Centre	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal function	Daily analysis of kidney function expressed in endogenous creatinine clearance	Baseline and every 24 hours until end ICU stay	No