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Levosimendan in Acute Kidney Injury Study

Phase 2
Conditions
Acute Kidney Injury
Interventions
Drug: Conventional therapy
Drug: Levosimendan
Registration Number
NCT01720030
Lead Sponsor
VieCuri Medical Centre
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
68
Inclusion Criteria
  • Clinically diagnosed adult patients with AKI
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional therapyConventional therapyStandard of care as protocolized locally
LevosimendanLevosimendanThe experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
Primary Outcome Measures
NameTimeMethod
Change in renal functionBaseline and every 24 hours until end ICU stay

Daily analysis of kidney function expressed in endogenous creatinine clearance

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

VieCuri Medical Center

🇳🇱

Venlo, Limburg, Netherlands

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