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OpenTrials
Completed

NCT Number: NCT02531724

Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

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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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Renal Insufficiency, Acute Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levosimendan

Drug

Other names: Simdax

Placebo

Drug

Sodium chloride

Primary outcomes

  1. Renal blood flow

    Time frame: 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.

  2. Glomerular filtration rate

    Time frame: 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 outcomes

  1. Serum creatinine

    Time frame: 4 days

    Measurement of serum creatinine will be made daily the first 4 days after the study

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: LEVOAKI

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2015
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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