Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

NCT05712434 | Completed DMC

• 1 other identifier: 202212030MIFA
• Study Type: interventional
• Target: 30,994
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Tract Infections

Keywords

chlorhexidine; catheter-related urinary tract infection; disinfection; bundle care; Foley catheter; urinary catheter

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter-related urinary tract infection

  The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)

  During the entire observation period (12 months)

Secondary Outcomes (2)

• Incidence of catheter-related urinary tract infection (including candiduria)

  During the entire observation period (12 months)

• Incidence of catheter-related urinary tract infection, by different clinical relevant isolates

  During the entire observation period (12 months)

Other Outcomes (1)

• The occurrence of severe adverse effects related to topical CHG disinfection

  During the entire observation period (12 months)

Study Arms (3)

Long CHG Intervention

EXPERIMENTAL

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

Other: Long Intervention

Mid-length CHG Intervention

EXPERIMENTAL

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

Other: Mid-length Intervention

Short CHG Intervention

EXPERIMENTAL

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

Other: Short Intervention

Interventions

Long Intervention OTHER

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.

Also known as: 4-month CHG and 6-month CHG plus

Long CHG Intervention

Mid-length Intervention OTHER

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.

Also known as: 4-month CHG and 4-month CHG plus

Mid-length CHG Intervention

Short Intervention OTHER

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.

Also known as: 4-month CHG and 2-month CHG plus

Short CHG Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• Hualien Tzu Chi General Hospital: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• Lotung Poh-Ai Hospital: collaborator
• Min-Sheng General Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Chromogranins

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Study Officials

• Yee-Chun Chen, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: March 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)