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

Not Applicable

• Conditions: Critical Illness
• Interventions: Device: normal CVC; Device: anti-infection CVC

• Registration Number: NCT02645682
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-05
• Study Start: 2016-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1818

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal CVC (Certofix®)	normal CVC	control group
anti-infection CVC (Certofix®protect)	anti-infection CVC	intervention group

Primary Outcome Measures

Name	Time	Method
catheter-related bloodstream infection	through study completion, an average of 2 years	number of participants with catheter-related bloodstream infection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China