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

Overview

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.

Full Title of Study: “Pharmacokinetics of Tigecycline in Critical Ill Patients Undergoing Continuous Renal Replacement Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Tigecycline Steady State Plasma Concentrations
    • Time Frame: Day 1-3
    • Steady State Plasma Concentration(Css) in blood

Secondary Measures

  • Peak Plasma Concentration(Cmax) of Tigecycline in blood
    • Time Frame: Day 1-3
  • Trough Plasma Concentration(Cmin) of Tigecycline in blood
    • Time Frame: Day 1-3
  • Area Under the Plasma Concentration versus Time Curve(AUC)
    • Time Frame: Day 1-3
  • Minimal Inhibitory Concentration(MIC)
    • Time Frame: Day 1-3

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhujiang Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wang Liqing, Doctor, Principal Investigator, Zhujiang Hospital,Southern Medical Unversity
  • Overall Contact(s)
    • Wang Liqing, Doctor, +86-02061643555, wliqing2014@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.