The Effects of Anti-infective Central Venous Catheter on Catheter-related Infection in Critically Patients

May 9, 2017 updated by: Kang Yan, West China Hospital

The Effects of Anti-infective Central Venous Catheter(CVC) on Catheter-related Bloodstream Infection(CRBSI) in Critical Care Patients: a Multiple-center, Randomized, Control Study

The purpose of this study is to investigate the effect of anti-infective central venous catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically ill patients in China, and the relationship between catheter-related bloodstream infection and catheter-related thrombosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1818

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Yao Chen, Doctor
  • Phone Number: (+86)153-0808-8233
  • Email: 314351895@qq.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Bin Du, Doctor
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Minming Wu

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients in intensive care unit (ICU)（age ≥ 18 years）
  • needs double lumen CVC more than 5 days
  • Signed informed consent

Exclusion Criteria:

  • thrombosis in target and/or contralateral vein
  • pregnancy or lactating women
  • unlikely to survive for more than 1 month
  • bad prognosis
  • suspected catheter-related infection
  • replacement CVC in original site through guide wire
  • severe burn
  • situation that is not suitable for CVC, including allergic to CVC material, thrombosis in target vein, infection of puncture site, coagulation disorder, abnormal anatomy
  • already in this study
  • participated in other studies within 3 months

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-infection CVC (Certofix®protect)
intervention group
Device: anti-infection CVC
Other Names:
  • Certofix®protect
Active Comparator: normal CVC (Certofix®)
control group
Device: normal CVC
Other Names:
  • Certofix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catheter-related bloodstream infection
Time Frame: through study completion, an average of 2 years
number of participants with catheter-related bloodstream infection
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catheter-related thrombosis
Time Frame: through study completion, an average of 2 years
number of participants with catheter-related thrombosis
through study completion, an average of 2 years
all cause mortality
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

West China Hospital

Collaborators

Peking Union Medical College Hospital

Investigators

  • Study Chair: Yan Kang, Doctor, West China Hospital
  • Study Chair: Bin Du, Doctor, Peking Union Medical College Hospital

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 (Actual)

March 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-I-H 1503

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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