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NCT01963013 Clinical Trial

Non-returning Catheter Valve for Reducing CAUTI

Critically Ill Patients Clinical Trial

Official title:
A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01963013
Other study ID # CAUTI-001
Secondary ID
Status Completed
Phase N/A
First received October 11, 2013
Last updated October 17, 2013
Start date June 2012
Est. completion date April 2013

Study information
Verified date October 2013
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority Thailand: Khon Kaen University Ethics Committee for Human Research
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Non-returning catheter valve

• Conventional urine bag

Locations
Country Name City State
Thailand Srinagarind hospital Muang Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence density of the catheter associated urinary tract infection (CAUTI) one year No
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