Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Acute Kidney Injury Renal Insufficiency, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sodium chloride

Interventions

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Levosimendan

Intervention Type DRUG

Placebo

Sodium chloride

Intervention Type DRUG

Other Intervention Names

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Simdax

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No