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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| Imec | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Other | Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem. |
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| Physicians | Other | Physicians in training or consultants who care for patients that are included in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prediction of plasma concentration of piperacillin-tazobactam or meropenem | Device | For included patients, a prediction will be made by developed machine learning models about the expected plasma concentration of piperacillin-tazobactam or meropenem by using routinely collected health care data. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations | 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration (determined via HPLC-MS/MS) trends | Trends in total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU | 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 |
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Patients
Inclusion Criteria:
Exclusion Criteria:
Consultants and physicians in training
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas De Corte, MD | Contact | 0032093324134 | thomas.decorte@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Jan De Waele, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Ghent | Ghent | 9000 | Belgium |
Individual participant data will be made available upon reasonable request and after approval by the appropriate ethical and regulatory bodies.
At publication of the results
Individual participant data will be made available upon reasonable request and after approval by the appropriate ethical and regulatory bodies.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Determination of plasma concentration of piperacillin-tazobactam or meropenem | Diagnostic Test | For included patients, the total plasma concentration of piperacillin-tazobactam or meropenem will be determined. Were possible, this will be done using a blood sample that was collected during routine daily bloodwork which is performed in the morning. If no routine sample is available, a study specific sample will be drawn at approximately the same time as a routine sample would be drawn. |
|
| Daily short questionnaire | Other | Physicians who care for patients included in the study will be asked to fill in a short daily questionnaire that evaluates the perceived necessity and added value of daily therapeutic drug monitoring. |
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The correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of renal (decline in urinary output, rise in serum creatinin), gastro-intestinal (C. difficile infections, stool consistency, elevation of ALT/AST/gamma GT/Alkalic fosfatase/INR/APTT/bilirubin), neurological (delirium as measured by Intensice Care Delirium Screening Checklist - ICDSC) or hematological (Rise or fall of thrombocytes, development of leucopenia/agranulocytosis/eosinophelia/hemolytic anemia) side effects. |
| Through study completion, an average of 1 year |
| Perceived necessity of therapeutic drug monitoring | The perceived necessity of therapeutic drug monitoring of consultants and physicians in training working in the ICU by evaluating the perceived necessity collected during the surveys with the measured plasma concentrations. | Through study completion, an average of 1 year |
| Perceived added value of therapeutic drug monitoring | The perceived added value of daily therapeutic drug monitoring from the responses to the survey | Through study completion, an average of 1 year |