Bacterial Infections
Conditions
Keywords
β-lactam, Bacterial Infections, Liver cirrhosis
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.
Interventions
DRUGβ-lactams
Participants receiving β-lactams were included.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | January 2018-December 2026 | 30-day mortality and 90-day mortality |
| Serum concentrations | January 2018-December 2026 | Serum concentrations of β-lactams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients reach clinical response at end of treatment | January 2018-December 2026 | By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms |
| Proportion of patients reach clinical response at day 4 of treatment | January 2018-December 2026 | By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms |
| Daily Sequential Organ Failure Assessment score change | January 2018-December 2026 | Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis. |
| Incidence of Septic Shock | January 2018-December 2026 | Incidence of Septic Shock |
| Safety outcome measures | January 2018-December 2026 | Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of β-lactams |
Countries
China
Contacts
CONTACTDayu Chen
PRINCIPAL_INVESTIGATORDayu Chen
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed