Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

NCT03101371 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-1096
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.

Conditions

Urinary Tract Infections; Catheter Infection; Catheter-Related Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)

  Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as \>10\^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.

  Within 14 +/- 2 days post-surgery

Secondary Outcomes (6)

• Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation

  Day 14 (+/- 2 days)

• Average Patient Satisfaction

  Day14 (+/- 2 days)

• Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)

  14 days (+/- 2 days) from surgery

• Number of Participants With Closed Drainage System Disrupted During Placement of Catheter

  Day 1 post op

• Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason

  Day 14 (+/- 2 days)

Study Arms (2)

Standard of care catheter insertion

ACTIVE COMPARATOR

Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.

Procedure: Standard of care catheter insertion

Aseptic protocol for catheter insertion

EXPERIMENTAL

Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter

Drug: Catheter insertion with Povidone Iodine

Interventions

Catheter insertion with Povidone Iodine DRUG

The catheter will be treated with Povidone Iodine prior to insertion.

Also known as: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter

Aseptic protocol for catheter insertion

Standard of care catheter insertion PROCEDURE

Catheter inserted right out of package.

Standard of care catheter insertion

Eligibility Criteria

• Age: 18 Years - 89 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 18-89 years of age
• admitted for surgery lasting \>1 hour and requiring urinary catheter,
• have normal urine analysis within 24 hours pre-surgery, and
• able to provide informed consent.

You may not qualify if:

• currently on dialysis,
• chronic urinary infection,
• hyperthyroidism,
• current infection,
• a history of allergy or sensitivity to iodine.
• women who are pregnant or breast feeding
• men due to their lower incidence of UTIs compared to the female population.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Catheter-Related Infections

Interventions

Catheterization; Povidone-Iodine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Saketh Guntupalli, MD
• Organization: University of Colorado, Anshcutz Medical Campus

saketh.guntupalli@cuanschutz.edu

303-724-2033

Study Officials

• Saketh Guntupalli, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery: 1. Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or 2. Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: October 10, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: March 10, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)