Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: β-lactams.
- Who it may be relevant to
- Registry conditions: Bacterial Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
Overview
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.
Interventions
- Drug β-lactams
Participants receiving β-lactams were included.
Primary outcome measures
- Mortality [Time frame: January 2018-December 2026]
- Serum concentrations [Time frame: January 2018-December 2026]
Secondary outcome measures (5)
- Proportion of patients reach clinical response at end of treatment [Time frame: January 2018-December 2026]
- Proportion of patients reach clinical response at day 4 of treatment [Time frame: January 2018-December 2026]
- Daily Sequential Organ Failure Assessment score change [Time frame: January 2018-December 2026]
- Incidence of Septic Shock [Time frame: January 2018-December 2026]
- Safety outcome measures [Time frame: January 2018-December 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing
Identifiers
NCT: NCT07612163 · 2023-298-02