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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhotic patients treated by β-lactams | Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by β-lactams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-lactams | Drug | Participants receiving β-lactams were included. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30-day mortality and 90-day mortality | January 2018-December 2026 |
| Serum concentrations | Serum concentrations of β-lactams | January 2018-December 2026 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reach clinical response at end of treatment | 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 |
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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
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Chinese adult cirrhotic patients with bacterial infections treated by β-lactams
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dayu Chen | Contact | +862583106666 | cdy_pharmacy@njglyy.com |
| Name | Affiliation | Role |
|---|---|---|
| Dayu Chen | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| January 2018-December 2026 |
| Proportion of patients reach clinical response at day 4 of treatment | 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 | January 2018-December 2026 |
| Daily Sequential Organ Failure Assessment score change | 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. | January 2018-December 2026 |
| Incidence of Septic Shock | Incidence of Septic Shock | January 2018-December 2026 |
| Safety outcome measures | Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of β-lactams | January 2018-December 2026 |
| D005355 |
| Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |