High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection

Catheter-related Bloodstream Infection Clinical Trial

Official title:

The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02990923
• Other study ID #: PekingHDNC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 2, 2016
• Last updated: December 12, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre

• Have signed information consent form

Exclusion Criteria:

• Have got bacteremia before catheter implantation

• Catheter changing in situ

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-related Bloodstream Infection
• Communicable Diseases
• Infection

Intervention

Device:
• High-Flow Needleless Valve

• DualCap Disinfection Devices

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter-related bloodstream infection		through study completion, an average of 1 year	Yes
Secondary	Number of participants with catheter withdraw for any reason		through study completion, an average of 1 year	Yes
Secondary	Number of participants with catheter dysfunction		through study completion, an average of 1 year	Yes