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

Sichuan University

Status: Unknown

Conditions: Critical Illness

Treatments: Device: normal CVC; Device: anti-infection CVC

Study type: Interventional

Funder types: Other

Identifiers

NCT02645682

HC-I-H 1503

Details and patient eligibility

About

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.

Enrollment: 1,818 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,818 participants in 2 patient groups

anti-infection CVC (Certofix®protect)

Experimental group

Description:

intervention group

Treatment:

Device: anti-infection CVC

normal CVC (Certofix®)

Active Comparator group

Description:

control group

Treatment:

Device: normal CVC