Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Chinese adult cirrhotic patients with bacterial infections treated by β-lactams

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • β-lactams

    Drug

    Participants receiving β-lactams were included.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Cirrhotic patients treated by β-lactams1 intervention

Trial outcomes

Primary outcomes

1

Mortality

30-day mortality and 90-day mortality

Time frame
January 2018-December 2026
2

Serum concentrations

Serum concentrations of β-lactams

Time frame
January 2018-December 2026

Secondary outcomes

1

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

Time frame
January 2018-December 2026
2

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

Time frame
January 2018-December 2026
3

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.

Time frame
January 2018-December 2026
4

Incidence of Septic Shock

Incidence of Septic Shock

Time frame
January 2018-December 2026

Other outcomes

Sponsors and contacts

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