Understanding how levosimendan behaves in critically ill patients with kidney issues
Levosimendans Pharmacokinetics in Intensive Care Patients
This study is trying to see how the heart medication levosimendan works in critically ill patients with different levels of kidney function to find out if their doses need to be adjusted.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05076864 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the pharmacokinetics of levosimendan and its metabolites in critically ill patients, particularly focusing on those with normal, reduced, and dialysis-supported renal function. The study aims to determine whether dose monitoring and adjustments of levosimendan are necessary to prevent toxicity or under-treatment. Conducted at Karolinska University Hospital, it will include adult patients prescribed levosimendan based on clinical need, categorized by the severity of acute kidney injury. The study will analyze how the drug and its metabolites are affected by renal function and continuous renal replacement therapy.
Who should consider this trial
Good fit: Ideal candidates are adult intensive care patients who require levosimendan treatment as determined by their physicians.
Not a fit: Patients under 18 years of age, pregnant individuals, and those receiving intermittent hemodialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for levosimendan in critically ill patients, enhancing treatment safety and efficacy.
How similar studies have performed: While this study focuses on a specific patient population, similar pharmacokinetic studies have shown promise in optimizing drug dosing in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Claire Rimes-Stigare, MD, PhD
- Email: claire.rimes-stigare@regionstockholm.se
- Phone: 004651770000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.