Levosimendans Pharmacokinetics in Intensive Care Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Concentration of levosimendan and OR 1896 1855 in plasma
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Claire Rimes-Stigare
Senior Consultant
Karolinska University Hospital