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Aseptic Protocol for Catheter Insertion to Reduce UTIs
NCT03101371Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2017
- Primary completion
- Feb 2019
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- povidone-iodine
- Conditions
- catheter-associated urinary tract infection (CAUTI)
01
Overview
Phase 2, randomised, open-label trial of povidone-iodine in catheter-associated urinary tract infection (CAUTI) (2 arms), sponsored by University of Colorado Denver. Primary endpoint: Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) at 14 days. Started Oct 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard of Care
Standard catheter insertion
Aseptic Protocol
Povidone-iodine treated catheter insertion
03
Who it enrols
Adult women (18-89) admitted for surgery lasting >1 hour requiring a urinary catheter, with normal pre-surgery urine analysis. Excludes patients on dialysis, with chronic urinary infection, hyperthyroidism, current infection, iodine allergy, or who are pregnant/breastfeeding.
04
Endpoints
Primary
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Secondary
Number of Participants Who Received the 'Fill and Pull' Versus the 'Pull and Void' Method of Catheter Discontinuation
Average Patient Satisfaction
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
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