NCT02990923

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 2, 2016

Last Update Submit

December 12, 2016

Conditions

Catheter-related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

  • Catheter-related bloodstream infection

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • 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

Study Arms (3)

Control

NO INTERVENTION

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

Only High-Flow Valve

EXPERIMENTAL

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

Both Divices

EXPERIMENTAL

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

Device: High-Flow Needleless ValveDevice: DualCap Disinfection Devices

Interventions

High-Flow Needleless ValveDEVICE
Both DivicesOnly High-Flow Valve
DualCap Disinfection DevicesDEVICE
Both Divices

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
  • Have signed information consent form

You may not qualify if:

  • Have got bacteremia before catheter implantation
  • Catheter changing in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice professor

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 13, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Last Updated

December 13, 2016

Record last verified: 2016-12