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

Sponsor

Peking University First Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02990923

Collaborator

(none)

102

Enrollment

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-related Bloodstream Infection	Device: High-Flow Needleless Valve Device: DualCap Disinfection Devices	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management
Experimental: Only High-Flow Valve In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management	Device: High-Flow Needleless Valve
Experimental: Both Divices In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis	Device: High-Flow Needleless Valve Device: DualCap Disinfection Devices

Arm

Intervention/Treatment

No Intervention: Control

In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management

Experimental: Only High-Flow Valve

In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management

Device: High-Flow Needleless Valve

Experimental: Both Divices

In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis

Device: High-Flow Needleless Valve

Device: DualCap Disinfection Devices

Outcome Measures

Primary Outcome Measures

Catheter-related bloodstream infection [through study completion, an average of 1 year]

Secondary Outcome Measures

Number of participants with catheter withdraw for any reason [through study completion, an average of 1 year]
Number of participants with catheter dysfunction [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University First Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rong Xu, vice professor, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT02990923

Other Study ID Numbers:

PekingHDNC

First Posted:

Dec 13, 2016

Last Update Posted:

Dec 13, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Infections

Communicable Diseases

Sepsis

Study Results

No Results Posted as of Dec 13, 2016