Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy

Conditions
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Bacterial Infection, Critically Ill

Intervention / Treatment
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* Drug: Tigecycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years,hospitalized ICU patients, male or female; having definitive diagnosis to treat with tigecycline for bacterial infection; receiving CRRT with renal insufficiency or not receiving CRRT with normal renal function. Exclusion Criteria: Patients with Child-Pugh C cirrhosis; Allergic to tetracycline or tigecycline; Patients received CRRT for < 3 days or treated with tigecycline < 3 days; Patients who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group CRRT<br>Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT | Drug: Tigecycline<br>* 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.<br>* Other names: Tygacil;|
| Group non-CRRT<br>Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT | Drug: Tigecycline<br>* 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.<br>* Other names: Tygacil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tigecycline Steady State Plasma Concentrations | Steady State Plasma Concentration(Css) in blood | Day 1-3 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | Day 1-3 | 
| Minimal Inhibitory Concentration(MIC) |  | Day 1-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tigecycline, Continuous Renal Replacement Therapy, Pharmacokinetics