Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05712434

Collaborator

National Taiwan University Hospital, Yun-Lin Branch (Other), Hualien Tzu Chi General Hospital (Other), National Taiwan University Hospital Hsin-Chu Branch (Other), Lotung Poh-Ai Hospital (Other), Min-Sheng General Hospital (Other)

15,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

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.
CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Other: Long Intervention Other: Mid-length Intervention Other: Short Intervention	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15000 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Each enrolled units will start with iodine protocol, and then switched to CHG protocol at designated time, followed by CHG plus protocol subsequently. 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.Each enrolled units will start with iodine protocol, and then switched to CHG protocol at designated time, followed by CHG plus protocol subsequently. 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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long CHG Intervention 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.	Other: Long Intervention Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. Other Names: 4-month CHG and 6-month CHG plus
Experimental: Mid-length CHG Intervention 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.	Other: Mid-length Intervention Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. Other Names: 4-month CHG and 4-month CHG plus
Experimental: Short CHG Intervention 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.	Other: Short Intervention Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. Other Names: 4-month CHG and 2-month CHG plus

Arm

Intervention/Treatment

Experimental: Long CHG Intervention

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

Other: Long Intervention

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other Names:

4-month CHG and 6-month CHG plus

Experimental: Mid-length CHG Intervention

4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.

Other: Mid-length Intervention

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other Names:

4-month CHG and 4-month CHG plus

Experimental: Short CHG Intervention

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

Other: Short Intervention

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other Names:

4-month CHG and 2-month CHG plus

Outcome Measures

Primary Outcome Measures

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

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.)

Other Outcome Measures

The occurrence of severe adverse effects related to topical CHG disinfection [During the entire observation period (12 months)]
The occurrence of severe adverse effects related to topical CHG disinfection

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically.

Inclusion Criteria (for units):

Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.

Exclusion Criteria (for units):

Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
Wards or intensive care units with patients aged below 18 years of age in their routine practice.