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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02931526

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infection Critically Ill	Drug: Tigecycline

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Group CRRT Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT	Drug: 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. Other Names: Tygacil
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	Drug: 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. Other Names: Tygacil

Arm

Intervention/Treatment

Group CRRT

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

Drug: 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.

Other Names:

Tygacil

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

Drug: 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.

Other Names:

Tygacil

Outcome Measures

Primary Outcome Measures

Tigecycline Steady State Plasma Concentrations [Day 1-3]
Steady State Plasma Concentration(Css) in blood

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.