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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftazidime-avibactam | Drug | Patients with severe sepsis and treatment with CAZ-AVI will be enrolled. Blood samples at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug concentrations of CAZ-AVI | Plasma drug concentrations of CAZ-AVI after the first time of drug administration | 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time of drug administration |
| Plasma drug concentrations of CAZ-AVI | Plasma drug concentrations of CAZ-AVI after the steady state concentration (more than 4 times drug administration) of drug administration | 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 |
| A population pharmacokinetic (PopPK) model for CAZ-AVI and to propose an appropriate dosing regimen in Chinese critically ill patients. | By conducting pharmacokinetic and pharmacodynamic analysis on the plasma drug concentration data of patients receiving CAZ-AVI treatment in the intensive care unit, we aim to develop a population pharmacokinetic (PopPK) model for critically ill patients in China and to formulate an appropriate dosing regimen for critically ill patients with varying degrees of renal function, including those undergoing renal replacement therapy. | After obtaining the patient's plasma drug concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Serum albumin | The level of serum albumin on the day of the first time of drug administration | The day of the first time of drug administration |
| Serum albumin | The level of serum albumin on the day of the steady state concentration(more than 4 times drug administration) of drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| YongHong Xiao, PhD | First Affiliated Hospital of Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,College of Medicine,Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
Respect ethics and protect patient privacy
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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| The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| The level of creatinine | The level of creatinine on the day of the first time of drug administration | The day of the first time of drug administration |
| The level of creatinine | The level of creatinine on the day of the steady state concentration(more than 4 times drug administration) of drug administration | The day of the first time of the steady state concentration (more than 4 times drug administration) of drug administration |
| The level of glomerular filtration rate | The level of glomerular filtration rate on the day of the first time of drug administration | The day of the first time of drug administration |
| The level of glomerular filtration rate | The level of glomerular filtration rate on the day of the steady state concentration (more than 4 times drug administration) of drug administration | The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| Whether received renal replacement therapy | Whether the patient received renal replacement therapy on the day of the first time of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the first time of drug administration |
| Whether received renal replacement therapy | Whether the patient received renal replacement therapy on the day of the steady state concentration (more than 4 times drug administration) of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| Respiratory function | Whether the patient received mechanical ventilation on the day of the first time of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the first time of administration |
| Respiratory function | Whether the patient received mechanical ventilation on the day of the steady state concentration (more than 4 times drug administration) of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| Cardiovascular function | Whether the patient received vasoactive agents(including norepinephrine, epinephrine, dobutamine, and metarylamine), and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the first time of drug administration |
| Cardiovascular function | Whether the patient received vasoactive agents(including norepinephrine, epinephrine, dobutamine, and metarylamine), and the results are recorded in the form of categorical variables,(e.g.,yes or no). | The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| CRRT treatment dosage | The specific parameters for patients undergoing CRRT include the type of CRRT machine, treatment modality, treatment method, filter type, treatment duration, pre-dilution volume, post-dilution volume, blood pump flow rate, dialysis pump flow rate, average hourly fluid removal, treatment dose, ultrafiltration rate, and waste fluid volume | The day of the first time of drug administration |
| CRRT treatment dosage | The specific parameters for patients undergoing CRRT include the type of CRRT machine, treatment modality, treatment method, filter type, treatment duration, pre-dilution volume, post-dilution volume, blood pump flow rate, dialysis pump flow rate, average hourly fluid removal, treatment dose, ultrafiltration rate, and waste fluid volume | The day of the steady state concentration (more than 4 times drug administration) of drug administration |
| microbiological clearance, infection-related mortality | microbiological clearance, 14 day infection-related mortality, | 14 day after the onset of infection |
| all-cause mortality | 30 day all-cause mortality,90 day all-cause mortality | 30 day and 90 day after the onset of infection |
| length of stay | Post-infection ICU length of stay | Day 1 is defined as the day of confirmed diagnosis, the duration from confirmed diagnosis to ICU discharge will be measured. |
| length of stay | Total ICU length of stay. | From ICU admission to ICU discharge will be measured(assessed up to 120 days). |
| D013568 |
| Pathological Conditions, Signs and Symptoms |