Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients

Zhejiang University

Status

Active, not recruiting

Conditions

Severe Sepsis

Treatments

Drug: Ceftazidime-avibactam

Study type

Observational

Funder types

Other

Identifiers

NCT05413343

2022-468

Details and patient eligibility

About

A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from June 1, 2021 to January 1, 2024. Patients with severe sepsis and treatment with Ceftazidime-avibactam (CAZ-AVI) will be enrolled.

Blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration will be collected to detect plasma drug concentrations of CAZ-AVI.

Full description

The investigators will collect the blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration from the patients receive treatment with CAZ-AVI to detect plasma drug concentrations of CAZ-AVI. The collected specimens will be stored in a refrigerator at 0-8 °C, centrifuges within 24 hours (4 °C, 4000 r/min, 10 min), and the supernatant will be collected in an EP tube and stored at -80°C until subsequent analysis. Ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS) will be used to detect plasma drug concentrations of CAZ-AVI. According to the outcomes ,the investigators will characterize the population pharmacokinetics (PPK) of CAZ-AVI in critically ill patients and performed pharmacodynamic target attainment analyses to determine optimal dosing regimens for patients with and without continuous renal replacement therapy (CRRT).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria