Investigating how liver cirrhosis affects ceftriaxone levels in patients
An Observational Explorative Study to Determine Pharmacokinetic Changes of Ceftriaxone in Blood and Ascites in Patients Admitted With Decompensated Liver Cirrhosis With or Without Renal Impairment.
This study is testing how liver cirrhosis affects the levels of the antibiotic ceftriaxone in patients who are receiving treatment for fluid buildup in their abdomen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05960006 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study aims to explore the pharmacokinetics of ceftriaxone in patients with decompensated liver cirrhosis who are undergoing paracentesis. A total of 20 adult patients will be monitored for changes in ceftriaxone levels in both blood and ascitic fluid during their treatment. The study will collect waste blood and ascites samples over a period of up to 48 hours after the last dose of ceftriaxone to assess clearance, volume of distribution, and penetration rates. The findings will help guide appropriate dosing of ceftriaxone in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with decompensated liver cirrhosis and ascites who are receiving ceftriaxone.
Not a fit: Patients without liver cirrhosis or those not receiving ceftriaxone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for ceftriaxone in patients with liver cirrhosis, reducing the risk of toxicity and enhancing treatment efficacy.
How similar studies have performed: While this study explores a specific pharmacokinetic aspect in a unique patient population, similar studies have shown the importance of tailored antibiotic dosing in patients with liver impairment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Clinical, radiological and/or histological diagnosis of liver cirrhosis and portal hypertension * Presence of ascites * Receiving ceftriaxone in the context of prophylaxis or treatment of infection * Indication for diagnostic and/or therapeutic paracentesis * Providing oral informed consent Exclusion Criteria: * None
Where this trial is running
Amsterdam
- Amsterdam university medical centers location AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marten Alexander Lantinga, MD PhD
- Email: m.a.lantinga@amsterdamumc.nl
- Phone: +31 6500 91290
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.