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Trial record 34 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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

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ClinicalTrials.gov Identifier: NCT03101371
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Catheter Infection Catheter-Related Infections Drug: Catheter insertion with Povidone Iodine Procedure: Standard of care catheter insertion Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients with normal 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. SOC catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care catheter insertion
Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Procedure: Standard of care catheter insertion
Catheter inserted right out of package.

Experimental: Aseptic protocol for catheter insertion
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
Drug: Catheter insertion with Povidone Iodine
The catheter will be treated with Povidone Iodine prior to insertion.
Other Name: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter




Primary Outcome Measures :
  1. Reduction in Urinary Tract Infections [ Time Frame: 14 +/- 2 days post-surgery ]
    Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Investigators plan to demonstrate that reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with UTIs and improve cost-effectiveness of care.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101371


Contacts
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Contact: Dina Flink, PhD 303-724-8467 dina.flink@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Dina Flink, PhD    303-724-8467    dina.flink@ucdenver.edu   
Principal Investigator: Saketh Guntupalli, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Saketh Guntupalli, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03101371     History of Changes
Other Study ID Numbers: 16-1096
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes