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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 flow

Glomerular 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

Page last updated: August 23, 2015

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