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Efficacy and population pharmacokinetics of carbapenems in patients with liver cirrhosis

A retrospective prospective cohort study on the efficacy and population pharmacokinetics of carbapenems in patients with liver cirrhosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086363
Enrollment
Unknown
Registered
2024-06-29
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Interventions

Observation group:N/A

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Retrospective cohort: (1) Adult (age = 18 years); (2) The clinical diagnosis was cirrhosis with clear indication of bacterial infection; (3) Use carbapenems for anti infection treatment; (4) He was admitted to Nanjing Drum Tower Hospital from January 2018 to August 2023. Prospective cohort: (1) Adult (age = 18 years old); (2) Clinically diagnosed as liver cirrhosis with clear indications of bacterial infection; (3) Using carbapenems for anti infection treatment; (4) Stayed at Nanjing Drum Tower Hospital from September 2023 to December 2026; (5) Sign informed consent and agree to join the study.

Exclusion criteria

Exclusion criteria: Retrospective cohort: (1) For various reasons, the treatment time of carbapenems is less than 72 hours; (2) Patients with severe adverse reactions after the application of carbapenems who cannot tolerate treatment; (3) According to the judgment of the research team, patients whose blood concentration monitoring time point did not meet the requirements of the study design; (4) Patients who are pregnant, pregnant, or breastfeeding; (5) Patients taking immunosuppressants at the same time; (6) Patients undergoing renal replacement therapy; (7) Patients undergoing extracorporeal membrane oxygenation; (8) Patients undergoing artificial liver or plasma exchange; (9) The infection flora was found to be carbapenem resistant patients after bacterial culture; (10) Patients with hematological tumors; (11) Patients with more missing clinical data and unable to determine the efficacy (12) Patients who are judged by the researcher team to be in other inappropriate situations Prospective cohort: (1) Due to various reasons, the treatment time of carbapenems is less than 72 hours; (2) Patients who experience severe adverse reactions after the application of carbapenems and cannot tolerate treatment; (3) Patients who are unable to monitor blood drug concentration at the designated time due to various reasons; (4) Pregnant, pregnant or breastfeeding patients; (5) Patients who are taking immunosuppressive agents simultaneously; (6) Patients undergoing renal replacement therapy; (7) Patients undergoing extracorporeal membrane oxygenation; (8) Patients undergoing artificial liver or plasma exchange; (9) After bacterial cultivation, it was found that the infected bacterial group is patients who are resistant to carbapenems; (10) Patients with concomitant hematological tumors; (11) According to the judgment of the research team, there are other patients who are not suitable for participating in this study or may not benefit the subjects from participating in the study; (12) The patient or client requests to withdraw from the study.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy at day 7;

Secondary

MeasureTime frame
Serum concentration of carbapenems;Mocrobial eradication rate at Day 7;Length of hospital stay;30 day mortality;Re-admission at day 30;Area under curve of SIRS score within first week after receiving therapy;AE;

Countries

China

Contacts

Public ContactDayu Chen

Nanjing Drum Tower Hospital

cdy_pharmacy@njglyy.com+86 159 5191 6689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026