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

• Conditions: Critically Ill; Bacterial Infection
• Interventions: Drug: Tigecycline

• Registration Number: NCT02931526
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-08
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group CRRT	Tigecycline	Patients who need to treat with tigecycline for bacterial infection, have renal insufficiency and have to treat with CRRT
Group non-CRRT	Tigecycline	Patients who need to treat with tigecycline for bacterial infection, have normal renal function in ICU and have no need to treat with CRRT

Primary Outcome Measures

Name	Time	Method
Tigecycline Steady State Plasma Concentrations	Day 1-3	Steady State Plasma Concentration(Css) in blood

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration(Cmax) 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
Trough Plasma Concentration(Cmin) of Tigecycline in blood	Day 1-3

Trial Locations

Locations (1)

Zhujiang Hospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China