About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Chinese adult cirrhotic patients with bacterial infections treated by β-lactams
Trial design
Cohort
Prospective
Treatments tested in this trial
β-lactams
DrugParticipants receiving β-lactams were included.
Treatment groups
Trial outcomes
Primary outcomes
Mortality
30-day mortality and 90-day mortality
Serum concentrations
Serum concentrations of β-lactams
Secondary outcomes
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
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
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.
Incidence of Septic Shock
Incidence of Septic Shock
Sponsors and contacts
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