Levosimendan in Acute Kidney Injury Study

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VieCuri Medical Centre
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

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