Levosimendans Pharmacokinetics in Intensive Care Patients. An Observational Study.
NCT ID: NCT05076864
Last Updated: 2021-10-13
Study Results
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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RECRUITING
12 participants
OBSERVATIONAL
2020-01-01
2025-12-31
Brief Summary
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Detailed Description
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Research questions:
1. To what extent are Levosimendan and its active metabolites dialysable in patients receiving continuous renal replacement therapy.
2. How do the concentrations of Levosimendan and its active metabolites differ in critically ill patients with and without acute renal failure?
Method:
The is a prospective observational study conducted on adult intensive care units at Karolinska University Hospital.
Study Population: Critical care patients who due to clinical need are prescribed Levosimendan by treating physician will be included into one of three groups based on degree of AKI (KDIGO classification) and need for CRRT. This is a non-interventional study.
Number of patients to be included: we intend to include 4-12 patients per group.
Procedure: The decision to prescribe Levosimendan will be made by treating physicians as will decisions regarding dose, dose adjustment and length of treatment.
Screening for inclusion will occur when a decision to prescribe Levosimendan has been made.
Samples of blood, urine and ultrafiltration fluid from the CRRT circuit are to be analysed to determine concentration of Levosimendan and its metabolites. Plasma concentrations will be obtained, before and after the dialysis filter.
Concentration monitoring will occur over a period of up to 6 days, with test taken at 0, 6 and 20 hours after infusion start and after cessation of Levosimendan every two hours for the first 10 hours and there after twice a day for the next 5 days. A maximum of 30 samples (15 in non CRRT patients) of 1-3ml are taken.
Patient groups:
Group 1: Levosimendan + no AKI or KDIGO AKI stage 1. Group 2: Levosimendan + KDIGO AKI stage 2-3, not CRRT Group 3: Levosimendan + KDIGO AKI stage 1-3 with CRRT.
Analysis:
Analysis of the plasma concentration of Levosimendan and its metabolites (OR-1896, OR-1855) is performed at the clinical pharmacology department, Karolinska University Hospital. Reference substances have been provided by Orion Pharma.
Definitions:
Acute Kidney Failure (AKI) is defined according to the KDIGO definition: Creatinine entry from the baseline (percentage increase) and volume of urine production or CRRT treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Patients receiving Intermittent hemodialysis
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Claire Rimes-Stigare
Senior Consultant
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-1951/2021
Identifier Type: -
Identifier Source: org_study_id