Clinical trial NCT05413343: Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
Official title: Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Severe Sepsis
Keywords: severe sepsis
Ceftazidime-avibactam
plasma drug concentration
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe sepsis and treatment with Ceftazidime-Avibactam in ICU of the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to September 30, 2022.

Brief summary: A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to January 1, 2024. Patients with severe sepsis and treatment with Ceftazidime-Avibactam 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 Ceftazidim-avibactam.

Detailed 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 Ceftazidime-Avibactam to detect plasma drug concentrations of Ceftazidime-avibactam. 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 Ceftazidime-avibactam. According to the outcomes ,the investigators will analyze the following items,(1)T\>MIC,(2)Cmax/MIC,(3)AUC/MIC,(4)population pharmacokinetics.

Eligibility criteria: Inclusion Criteria:

* Patients with severe sepsis and treated with ceftazidime avibactam
* Age ≥ 18 years
* The patient or authorized persons agree and sign the informed consent
* The patient's hemoglobin is greater than 70g/l during blood collection

Exclusion Criteria:

* The expected length of ICU stay less than 48 hours,
* Pregnant woman,
* The blood sample is hemolysis.

Primary outcomes:
measure: Plasma drug concentrations of Ceftazidime-avibactam
timeFrame: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time of drug administration
measure: Plasma drug concentrations of ceftazidime avibactam
timeFrame: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the steady state concentration (more than 4 times drug administration) of drug administration
Secondary outcomes:
measure: Serum albumin
timeFrame: The day of the first time of drug administration
measure: Serum albumin
timeFrame: The day of the steady state concentration (more than 4 times drug administration) of drug administration
measure: The level of creatinine
timeFrame: The day of the first time of drug administration
measure: The level of creatinine
timeFrame: The day of the first time of the steady state concentration (more than 4 times drug administration) of drug administration
measure: The level of glomerular filtration rate
timeFrame: The day of the first time of drug administration
measure: The level of glomerular filtration rate
timeFrame: The day of the steady state concentration (more than 4 times drug administration) of drug administration
measure: Whether received renal replacement therapy
timeFrame: The day of the first time of drug administration
measure: Whether received renal replacement therapy
timeFrame: The day of the steady state concentration (more than 4 times drug administration) of drug administration
measure: Respiratory function
timeFrame: The day of the first time of administration
measure: Respiratory function
timeFrame: The day of the steady state concentration (more than 4 times drug administration) of drug administration
measure: Cardiovascular function
timeFrame: The day of the first time of drug administration
measure: Cardiovascular function
timeFrame: The day of the steady state concentration (more than 4 times drug administration) of drug administration
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital,College of Medicine,Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: YongHong Xiao, PhD
role: STUDY_CHAIR
References: