Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery (LEVOAKI)

Sahlgrenska University Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury; Renal Insufficiency, Acute

Treatments: Drug: Levosimendan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02531724

SahlgrenskaUHThoraxLL3

Details and patient eligibility

About

Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery.

In order to investigate the effect of levosimendan in patients with AKI after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and Chromium ethylenediaminetetraacetic acid (Cr-EDTA) respectively.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass
• Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L
• Normal S-creatinine before surgery

Exclusion criteria

• Ongoing treatment with inotropic drugs (not norepinephrine)
• Central venous oxygen saturation (ScvO2) < 60% despite optimization of hematocrit and volume status
• Need of renal replacement therapy
• Ongoing bleeding
• Patient or next of kin does not consent with study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Levosimendan

Active Comparator group

Description:

Levosimendan will be given as a loading dose of 12 ug/kg during 30 minutes, and then a continuous infusion of 0,1 ug/kg/min for 180 minutes.

Treatment:

Drug: Levosimendan

Placebo

Placebo Comparator group

Description:

Sodium chloride will be given as a loading dose during 30 minutes and then a continuous infusion for 180 minutes at a rate mimicking the levosimendan group above.

Treatment:

Drug: Placebo