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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery (LEVOAKI)

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ClinicalTrials.gov Identifier: NCT02531724
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Lukas Lannemyr, 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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Renal Insufficiency, Acute Drug: Levosimendan Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Study Start Date : September 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: 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.
Drug: Levosimendan
Other Name: Simdax

Placebo Comparator: 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.
Drug: Placebo
Sodium chloride




Primary Outcome Measures :
  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 Outcome Measures :
  1. Serum creatinine [ Time Frame: 4 days ]
    Measurement of serum creatinine will be made daily the first 4 days after the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531724


Contacts
Contact: Lukas Lannemyr, M D +46-31-3428860 lukas.lannemyr@vgregion.se
Contact: Sven-Erik Ricksten, Professor sven-erik.ricksten@aniv.gu.se

Locations
Sweden
Department of thoracic anesthesia, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Lukas Lannemyr, MD    +46-31-3428860    lukas.lannemyr@vgregion.se   
Contact: Sven-Erik Ricksten, Professor       sven-erik.ricksten@aniv.gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Study Director: Sven-Erik Ricksten, Professor Sahlgrenska Academy, dept of clinical science

Publications:
Responsible Party: Lukas Lannemyr, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02531724     History of Changes
Other Study ID Numbers: SahlgrenskaUHThoraxLL3
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by Lukas Lannemyr, Sahlgrenska University Hospital, Sweden:
acute kidney injury
cardiac surgery
renal blood flow
levosimendan

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs