Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Information source: Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Kidney Injury; Renal Insufficiency, Acute
Intervention: Levosimendan (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Sahlgrenska University Hospital, Sweden Overall contact: Lukas Lannemyr, Phone: +46-31-3428860, Email: lukas.lannemyr@vgregion.se
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.
Clinical Details
Official title: Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Renal blood flowGlomerular filtration rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lukas Lannemyr, Phone: +46-31-3428860, Email: lukas.lannemyr@vgregion.se
Department of thoracic anesthesia, Sahlgrenska University Hospital, Gothenburg 41345, Sweden
Additional Information
Related publications: Bragadottir G, Redfors B, Ricksten SE. Effects of levosimendan on glomerular filtration rate, renal blood flow, and renal oxygenation after cardiac surgery with cardiopulmonary bypass: a randomized placebo-controlled study. Crit Care Med. 2013 Oct;41(10):2328-35. doi: 10.1097/CCM.0b013e31828e946a.
Starting date: September 2015
Last updated: August 20, 2015
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