PharmacokineticsLEFKIPNCT05076864
Levosimendans Pharmacokinetics in Intensive Care Patients. An Observational Study.
An observational study of Pharmacokinetics and Metabolites, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Metabolites, Intensive Care
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive Care Unit patients in whom the treating physician has decided due to clinical indication to administer levosimendan. Dose and length of treatment decided by treating physician. With Group 1: No renal failure or Acute Kidney Injury(AKI)* stage 1. Group 2: AKI stage 2-3, not receiving renal replacement therapy. Group 3: Receiving continuous renal replacement therapy (CRRT) *AKI classification system Kidney Disease Improving Global outcomes (KDIGO)
Who may be able to join
- ° Adult Intensive care patients in whom treating physicians have judged to be in need of Levosimendan treatment.
Who cannot join
- Patient <18 years of age
- Pregnancy
- Patients receiving Intermittent hemodialysis
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Susanne, MD, 004651770000, sussanne.rysz@regionstockholm.se
Claire Rimes-Stigare, MD, PhD, 004651770000, claire.rimes-stigare@regionstockholm.se
About this study
Official title: Levosimendans Pharmacokinetics in Intensive Care Patients
Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function.
Read the detailed description
Aims: To gain a better understanding of the pharmacokinetics of Levosimendan in critically ill patients and in particular in those patients with and without renal failure and in those receiving CRRT. This project may give a better basis to determine whether dose monitoring and adjustment of Levosimendan is necessary to avoid toxicity or under treatment. In order to study Levosimendan pharmacokinetics, the Karolinska laboratory has in parallel developed a method for analysis of the substance and its metabolites.
Research questions:
- To what extent are Levosimendan and its active metabolites dialysable in patients receiving continuous renal replacement therapy.
- 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.
- Being tested
- No intervention
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of levosimendan and OR 1896 1855 in plasma
Plasma concentrations of levosimendan and its active metabolites afte Levosimendan infusion.
Measured: 1-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Claire Rimes-Stigare, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076864
- Sponsor's protocol ID
- 4-1951/2021
- Acronym
- LEFKIP
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendans Pharmacokinetics in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05076864
- Acronym / sponsor ID
- LEFKIP / 4-1951/2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function.
Detailed description
Aims: To gain a better understanding of the pharmacokinetics of Levosimendan in critically ill patients and in particular in those patients with and without renal failure and in those receiving CRRT. This project may give a better basis to determine whether dose monitoring and adjustment of Levosimendan is necessary to avoid toxicity or under treatment. In order to study Levosimendan pharmacokinetics, the Karolinska laboratory has in parallel developed a method for analysis of the substance and its metabolites.
Research questions:
- To what extent are Levosimendan and its active metabolites dialysable in patients receiving continuous renal replacement therapy.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care Unit patients in whom the treating physician has decided due to clinical indication to administer levosimendan. Dose and length of treatment decided by treating physician. With Group 1: No renal failure or Acute Kidney Injury(AKI)* stage 1. Group 2: AKI stage 2-3, not receiving renal replacement therapy. Group 3: Receiving continuous renal replacement therapy (CRRT) *AKI classification system Kidney Disease Improving Global outcomes (KDIGO)
Key inclusion criteria (1 listed)
- ° Adult Intensive care patients in whom treating physicians have judged to be in need of Levosimendan treatment.
Key exclusion criteria (3 listed)
- Patient <18 years of age
- Pregnancy
- Patients receiving Intermittent hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Concentration of levosimendan and OR 1896 1855 in plasma
Time frame: 1-5 days
Plasma concentrations of levosimendan and its active metabolites afte Levosimendan infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Metabolites, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Rimes-Stigare, MD, PhD (004651770000, claire.rimes-stigare@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of levosimendan and OR 1896 1855 in plasma (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.