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| Name | Class |
|---|---|
| Institute of Antibiotics, Huashan Hospital, Fudan University | UNKNOWN |
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This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem | Patients requiring dialysis and receiving meropenem for infection or suspended infection. |
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| Vancomycin | Patients requiring dialysis and receiving vancomycin for infection or suspended infection. |
| |
| Ceftriaxone | Patients requiring dialysis and receiving ceftriaxone for infection or suspended infection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and spent dialysate collection | Other | A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dialytic clearance (K_total) | The total drug amount removed by dialysis | During the session of dialysis, up to 4 hours |
| Area under the concentration-time curve (AUC) | AUC based on plasma concentration during dialysis | During the session of dialysis, up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rebound of plasma concentration (Rebound_1h%) | The rebound rate of plasma concentration 1 hour after dialysis | At the end of dialysis and an hour after dialysis |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients aged from 18 to 85 years, requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai, China.
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| Name | Affiliation | Role |
|---|---|---|
| Feng Ding, PhD | Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |