Acute Kidney Injury, Renal Insufficiency, Acute
Conditions
Keywords
acute kidney injury, cardiac surgery, renal blood flow, levosimendan
Brief summary
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.
Interventions
DRUGLevosimendan
DRUGPlacebo
Sodium chloride
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal blood flow | 5 Hours | 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. |
| Glomerular filtration rate | 5 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | 4 days | Measurement of serum creatinine will be made daily the first 4 days after the study |
Countries
Sweden
Outcome results
None listed