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The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and examine whether the dosage needs adjustment.
The study will observe two groups of patients respectively and compare the difference between them. Patients who need to receive CRRT when treat with high-dose tigecycline will be collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected in Group non-CRRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CRRT | Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT |
| |
| Group non-CRRT | Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigecycline | Drug | Patients who have the definitive diagnosis to treat with tigecycline for bacterial infection will be started on tigecycline with a loading dose 200mg IV followed by 100mg IV every 12h. |
| Measure | Description | Time Frame |
|---|---|---|
| Tigecycline Steady State Plasma Concentrations | Steady State Plasma Concentration(Css) in blood | Day 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration(Cmax) of Tigecycline in blood | Day 1-3 | |
| Trough Plasma Concentration(Cmin) of Tigecycline in blood | Day 1-3 | |
| Area Under the Plasma Concentration versus Time Curve(AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Liqing, Doctor | Contact | +86-02061643555 | wliqing2014@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Liqing, Doctor | Zhujiang Hospital,Southern Medical Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital,Southern Medical University | Recruiting | Guangzhou | Guangdong | 510282 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32716292 | Derived | Zhao HH, Tang WJ, Yang YX, Cen ZR, Wang LQ. PK/PD study of tigecycline in severely infected patients with continuous renal replacement therapy. Int J Clin Pharmacol Ther. 2020 Oct;58(10):531-538. doi: 10.5414/CP203669. |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Whole blood, serum, urine, effluent fluid from dialysis machine
|
| Day 1-3 |
| Minimal Inhibitory Concentration(MIC) | Day 1-3 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |