Validation of Uncertainty Quantifying Machine Learning Models to Predict Beta-lactam Antimicrobial Concentrations in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations
研究概览
简要总结
The goal of this study is to learn about the real wold behavior of developed machine learning models that predict the plasma concentration of piperacillin-tazobactam and meropenem in critically ill patients admitted to the intensive care unit (ICU).
The main aim of the study is to validate the performance of these machine learning models. To this end, daily measured plasma concentrations of the investigated antimicrobials will be compared with the predicted concentration by the machine learning algorithms.
Additional goals of the study include:
- To describe the total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU.
- To quantify the correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of side effects.
- To evaluate the perceived necessity of therapeutic drug monitoring (TDM) of consultants and physicians in training working in the ICU.
- To evaluate the perceived added value of daily TDM.
Samples (where possible taken routinely) from participating patients will be analyzed for meropenem and piperacillin-tazobactam plasma concentration. Participating physicians will be asked to fill in a short daily questionnaire during the time a patient under their care is treated with the antimicrobial under investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Admission to the ICU.
- •Age above 18 years old.
- •Treatment with piperacillin-tazobactam or meropenem for less than 48 hours.
排除标准
- •Pregnant or lactating patients.
- •Limitation of therapy beyond "Do not resuscitate".
- •Expected demise within 48 hours after inclusion.
- •Haemoglobin < 7 g/dL.
- •Previous inclusion in this study for a treatment course with the same antimicrobial.
- •Consultants and physicians in training
- •Inclusion Criteria:
- •Consultant or physician in training working in the ICU.
- •Exclusion Criteria:
研究组 & 干预措施
Patients
Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem.
干预措施: Prediction of plasma concentration of piperacillin-tazobactam or meropenem (Device)
Patients
Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem.
干预措施: Determination of plasma concentration of piperacillin-tazobactam or meropenem (Diagnostic Test)
Physicians
Physicians in training or consultants who care for patients that are included in the study.
干预措施: Daily short questionnaire (Other)
结局指标
主要结局
Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations
时间窗: Through study completion, an average of 1 year
The difference between the predicted concentration (from the TDMAide software) and the concentration range based on the measured concentration (measured from the blood sample from the patient and analyzed using a HPLC-MS/MS method, with and without taking into account intra- and inter measurement variabilities of the HPLC-MS/MS method.
次要结局
- Perceived added value of therapeutic drug monitoring(Through study completion, an average of 1 year)
- Perceived necessity of therapeutic drug monitoring(Through study completion, an average of 1 year)
- Plasma concentration (determined via HPLC-MS/MS) trends(Through study completion, an average of 1 year)
- Correlation between plasma concentrations (measured by HPLC-MS/MS) and side effects as percentage of patients experiencing the side effect(Through study completion, an average of 1 year)