A Study to Determine Pharmacokinetic Changes of Ceftriaxone in Patients With Liver Cirrhosis

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes the antibiotic ceftriaxone in patients with liver cirrhosis, a condition where the liver is severely damaged. Researchers want to understand how this medication behaves in the blood and fluid that builds up in the abdomen (called ascites) in these patients. The study will include 20 adults aged 18 and older who have been diagnosed with liver cirrhosis and have fluid in their abdomen. To participate, they must be receiving ceftriaxone and scheduled for a procedure called paracentesis, which involves removing excess fluid.

Participants in the study can expect to provide blood and fluid samples at various times during their hospital stay. The researchers will collect these samples starting when the patient joins the study and for up to 48 hours after their last dose of ceftriaxone. The study will last for about 12 months, with 1-2 new participants expected each month. Importantly, joining this study will not change the patient's treatment or hospital stay, as those decisions will be made by their doctor.

Gender

ALL

Eligibility 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