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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645682

Enrollment

1818

Registered

2016-01-05

Start date

2016-03-31

Completion date

2018-12-31

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

central venous catheter (CVC), catheter-related bloodstream infection (CRBSI), catheter-related thrombosis (CRT)

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.

Interventions

DEVICEanti-infection CVC

DEVICEnormal CVC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactYan Kang, Doctor

kangyan_hx@163.com(+86)189-8060-1566

Backup ContactYao Chen, Doctor

314351895@qq.com(+86)153-0808-8233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026