LEFKIP: Levosimendans Pharmacokinetics in Intensive Care Patients. An Observational Study.

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076864
Collaborator
Karolinska University Hospital (Other)
12
Enrollment
1
Location
72
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of the pharmacokinetics of levosimendan and its metabolites in intensive care patients with normal, reduced and dialysis supported renal function.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: No intervention

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:
  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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Levosimendans Pharmacokinetics in Intensive Care Patients
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Concentration of levosimendan and OR 1896 1855 in plasma [1-5 days]

    Plasma concentrations of levosimendan and its active metabolites afte Levosimendan infusion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

° Adult Intensive care patients in whom treating physicians have judged to be in need of Levosimendan treatment.

Exclusion Criteria:
  • Patient <18 years of age

  • Pregnancy

  • Patients receiving Intermittent hemodialysis

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Karolinska University HospitalStockholmSweden

Sponsors and Collaborators

  • Karolinska Institutet
  • Karolinska University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Claire Rimes-Stigare, Senior Consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT05076864
Other Study ID Numbers:
  • 4-1951/2021
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021