Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery (LEVOAKI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02531724|
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : October 4, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
- Serum creatinine [ Time Frame: 4 days ]Measurement of serum creatinine will be made daily the first 4 days after the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531724
|Contact: Lukas Lannemyr, M Demail@example.com|
|Contact: Sven-Erik Ricksten, Professorfirstname.lastname@example.org|
|Department of thoracic anesthesia, Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 41345|
|Contact: Lukas Lannemyr, MD +46-31-3428860 email@example.com|
|Contact: Sven-Erik Ricksten, Professor firstname.lastname@example.org|
|Study Director:||Sven-Erik Ricksten, Professor||Sahlgrenska Academy, dept of clinical science|