Clinical trial NCT02645682: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: central venous catheter (CVC)
catheter-related bloodstream infection (CRBSI)
catheter-related thrombosis (CRT)
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
First posted: 2016-01-05
Enrollment: 1818
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: catheter-related bloodstream infection
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: catheter-related thrombosis
timeFrame: through study completion, an average of 2 years
measure: all cause mortality
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Yan Kang, Doctor
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Bin Du, Doctor
role: STUDY_CHAIR
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