Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Other: Long Intervention; Other: Mid-length Intervention; Other: Short Intervention

• Registration Number: NCT05712434
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:

1. Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.

2. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.

3. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.

Detailed Description

This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):

Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.

Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.

Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.

All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-03-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30994

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Long CHG Intervention	Long Intervention	2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.
Mid-length CHG Intervention	Mid-length Intervention	4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.
Short CHG Intervention	Short Intervention	6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-related urinary tract infection	During the entire observation period (12 months)	The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)

Secondary Outcome Measures

Name	Time	Method
Incidence of catheter-related urinary tract infection (including candiduria)	During the entire observation period (12 months)	The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network, but candiduria not excluded as pathogen
Incidence of catheter-related urinary tract infection, by different clinical relevant isolates	During the entire observation period (12 months)	The incidence of CAUTI caused by different clinical relevant isolates (Pseudomonas aeruginosa, enterococci, enteric gram-negative bacteria, other pseudomonads, etc.)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan