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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 March 2021 |
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Main ID: |
NCT02531724 |
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Date of registration:
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20/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
LEVOAKI |
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Scientific title:
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Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02531724 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Sven-Erik Ricksten, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska Academy, dept of clinical science |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Kidney Injury
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Renal Insufficiency, Acute
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Intervention(s)
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Drug: Levosimendan
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Drug: Placebo
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Primary Outcome(s)
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Glomerular filtration rate
[Time Frame: 5 Hours]
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Renal blood flow
[Time Frame: 5 Hours]
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Secondary Outcome(s)
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Serum creatinine
[Time Frame: 4 days]
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Secondary ID(s)
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SahlgrenskaUHThoraxLL3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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