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

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anti-infection CVC
normal CVC
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring central venous catheter (CVC), catheter-related bloodstream infection (CRBSI), catheter-related thrombosis (CRT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

anti-infection CVC (Certofix®protect)

normal CVC (Certofix®)

Arm Description

intervention group

control group

Outcomes

Primary Outcome Measures

catheter-related bloodstream infection
number of participants with catheter-related bloodstream infection

Secondary Outcome Measures

catheter-related thrombosis
number of participants with catheter-related thrombosis
all cause mortality

Full Information

First Posted
December 30, 2015
Last Updated
May 9, 2017
Sponsor
West China Hospital
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02645682
Brief Title
The Effects of Anti-infective Central Venous Catheter on Catheter-related Infection in Critically Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
Collaborators
Peking Union Medical College Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
central venous catheter (CVC), catheter-related bloodstream infection (CRBSI), catheter-related thrombosis (CRT)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1818 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-infection CVC (Certofix®protect)
Arm Type
Experimental
Arm Description
intervention group
Arm Title
normal CVC (Certofix®)
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
anti-infection CVC
Other Intervention Name(s)
Certofix®protect
Intervention Type
Device
Intervention Name(s)
normal CVC
Other Intervention Name(s)
Certofix®
Primary Outcome Measure Information:
Title
catheter-related bloodstream infection
Description
number of participants with catheter-related bloodstream infection
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
catheter-related thrombosis
Description
number of participants with catheter-related thrombosis
Time Frame
through study completion, an average of 2 years
Title
all cause mortality
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Kang, Doctor
Phone
(+86)189-8060-1566
Email
kangyan_hx@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Chen, Doctor
Phone
(+86)153-0808-8233
Email
314351895@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Kang, Doctor
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bin Du, Doctor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Du, Doctor
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Kang, Doctor
Phone
(+86)189-8060-1566
Email
kangyan_hx@163.com
First Name & Middle Initial & Last Name & Degree
Yao Chen, Doctor
Phone
(+86)153-0808-8233
Email
314351895@qq.com
First Name & Middle Initial & Last Name & Degree
Minming Wu

12. IPD Sharing Statement

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

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