Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Phase 4

Completed

• Conditions: Renal Insufficiency, Acute; Acute Kidney Injury
• Interventions: Drug: Placebo; Drug: Levosimendan

• Registration Number: NCT02531724
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-24
• Study Start: 2015-09
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Levosimendan	Levosimendan	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Serum creatinine	4 days	Measurement of serum creatinine will be made daily the first 4 days after the study

Trial Locations

Locations (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden