Levosimendan in Acute Kidney Injury Study

NCT01720030 | Unknown Phase 2 DMC

• 1 other identifier: Levosimendan in AKI Study
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury

Keywords

Renal; Acute Kidney Injury; AKI; Levosimendan; Simdax; Renal perfusion; Mortality; Renal flow

Outcome Measures

Primary Outcomes (1)

• Change in renal function

  Daily analysis of kidney function expressed in endogenous creatinine clearance

  Baseline and every 24 hours until end ICU stay

Study Arms (2)

Conventional therapy

PLACEBO COMPARATOR

Standard of care as protocolized locally

Drug: Conventional therapy

Levosimendan

EXPERIMENTAL

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

Interventions

Levosimendan DRUG

Verum therapy

Also known as: Simdax (R)

Levosimendan

Conventional therapy DRUG

Placebo therapy to safeguard blinding

Also known as: Standard care plus placebo comparator

Conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed adult patients with AKI

You may not qualify if:

• 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

Sponsors & Collaborators

• VieCuri Medical Centre: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

VieCuri Medical Center

Venlo, Limburg, NL-5912 BL, Netherlands

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Simendan; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jos Le Noble, MD PhD

  VieCuri Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: November 1, 2012
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

NL (1)