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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02931526

Enrollment

Registered

2016-10-13

Start date

2016-08-31

Completion date

Unknown

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection, Critically Ill

Keywords

Tigecycline, Continuous Renal Replacement Therapy, Pharmacokinetics

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.

Interventions

DRUGTigecycline

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Contacts

Primary ContactWang Liqing, Doctor

wliqing2014@163.com+86-02061643555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026