NCT01963013

Brief Summary

This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

October 11, 2013

Last Update Submit

October 17, 2013

Conditions

Catheter Associated Urinary Tract InfectionCritically Ill Patients

Keywords

Non-returning catheter valveCatheter associated urinary tract infectionCritically ill patientsPrevention

Outcome Measures

Primary Outcomes (1)

  • Incidence density of the catheter associated urinary tract infection (CAUTI)

    one year

Study Arms (2)

Non-returning catheter valve

EXPERIMENTAL

Non-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only.

Device: Non-returning catheter valve

Conventional urine bag

ACTIVE COMPARATOR

Conventional urine bag hasn't the non-returning catheter valve.

Device: Conventional urine bag

Interventions

Non-returning catheter valveDEVICE
Also known as: UnometerTM SafetiTM Plus
Non-returning catheter valve
Conventional urine bagDEVICE
Conventional urine bag

Eligibility Criteria

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

You may qualify if:

  • The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
  • All participants must be retained the urinary catheter.

You may not qualify if:

  • The participants were diagnosed urinary tract infection before retention of the urinary catheter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind hospital

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • Panitchote A, Charoensri S, Chetchotisakd P, Hurst C. Pilot study of a non-return catheter valve for reducing catheter-associated urinary tract infections in critically ill patients. J Med Assoc Thai. 2015 Feb;98(2):150-5.

    PMID: 25842795DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anupol Panitchote

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 16, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

TH(1)