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

October 10, 2016 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital,Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized Intensive Care Unit(ICU) patients in Zhujiang Hospital, in need of treatment with antiinfectives

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Wang Liqing, Doctor, Zhujiang Hospital,Southern Medical Unversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCYJ1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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