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Non-returning Catheter Valve for Reducing CAUTI

Primary Purpose

Catheter Associated Urinary Tract Infection, Critically Ill Patients

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Non-returning catheter valve
Conventional urine bag
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter Associated Urinary Tract Infection focused on measuring Non-returning catheter valve, Catheter associated urinary tract infection, Critically ill patients, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Srinagarind hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-returning catheter valve

Conventional urine bag

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2013
Last Updated
October 17, 2013
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01963013
Brief Title
Non-returning Catheter Valve for Reducing CAUTI
Official Title
A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Associated Urinary Tract Infection, Critically Ill Patients
Keywords
Non-returning catheter valve, Catheter associated urinary tract infection, Critically ill patients, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-returning catheter valve
Arm Type
Experimental
Arm Description
Non-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only.
Arm Title
Conventional urine bag
Arm Type
Active Comparator
Arm Description
Conventional urine bag hasn't the non-returning catheter valve.
Intervention Type
Device
Intervention Name(s)
Non-returning catheter valve
Other Intervention Name(s)
UnometerTM SafetiTM Plus
Intervention Type
Device
Intervention Name(s)
Conventional urine bag
Primary Outcome Measure Information:
Title
Incidence density of the catheter associated urinary tract infection (CAUTI)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: The participants were diagnosed urinary tract infection before retention of the urinary catheter.
Facility Information:
Facility Name
Srinagarind hospital
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25842795
Citation
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.
Results Reference
derived

Learn more about this trial

Non-returning Catheter Valve for Reducing CAUTI

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