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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

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.

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Detailed Description

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Conditions

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Bacterial Infection Critically Ill

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group CRRT

Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT

Tigecycline

Intervention Type 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.

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

Tigecycline

Intervention Type 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.

Interventions

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Tigecycline

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.

Intervention Type DRUG

Other Intervention Names

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Tygacil

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No