Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
Study Overview
Brief Summary
Patients may benefit from the personalized β-lactams dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review, prospective observe and analyze the clinical outcomes of patients with liver cirrhosis, and to build a population pharmacokinetics model in the population mentioned above.
Detailed Description
Rational use of β-lactams is closely associated with the clinical outcome of patients with infections. Serum concentration of β-lactams varies from different populations. The objective of this study is to describe the clinical outcome of cirrhotic patients with infection treated by β-lactams in China, regarding diagnosis, treatment and follow-up. It is a single-center, retro-prospective, observational study. Inclusion criteria are an age ≥ 18, liver cirrhosis, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.
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
- •Age over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy
Exclusion Criteria
- •Duration of β-lactams treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of β-lactams
Investigators
Chen Dayu
Pharmacist in Charge
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School