Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Conditions
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Acute Kidney Injury, Renal Insufficiency, Acute

Intervention / Treatment
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* Drug: Levosimendan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levosimendan<br>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. | Drug: Levosimendan<br> <br> * Other names: Simdax;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal blood flow | Renal blood flow will be measured using infusion clearance technique of para-aminohippuric acid. Measurements will be made in duplicates before and after administration of the study drug. | 5 Hours | 
| Glomerular filtration rate | Filtration fraction will be determined using be measured using infusion clearance technique of Chromium ethylenediaminetetraacetic acid (Cr-EDTA). Measurements will be made in duplicates before and after administration of the study drug. Glomerular filtration rate will be calculated as the filtration fraction multiplied by renal plasma flow. | 5 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine | Measurement of serum creatinine will be made daily the first 4 days after the study | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, cardiac surgery, renal blood flow, levosimendan