Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447639
Recruitment Status : Terminated (Lack of Patient Enrollment)
First Posted : February 27, 2018
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jay Hollander MD, William Beaumont Hospitals

Brief Summary:
Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.

Condition or disease Intervention/treatment Phase
Catheter; Infection (Indwelling Catheter) Catheter Infection Catheter-Related Infections Catheter Bacteraemia Urinary Tract Infections Drug: Povidone-iodine irrigation Phase 4

Detailed Description:

Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of reasons, including monitoring of urine output in critically ill patients, relief of urinary obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% each day a catheter is left in place, meaning that by 30 days, generally 100% of patients with indwelling catheters will have bacteria in their urine. The majority of these people do not have urinary tract infections (UTIs), they are merely colonized and do not require treatment.

To define a standard (and ultimately to compare hospitals against each other), a surveillance definition for CAUTI has been developed by the National Healthcare Safety Network (NHSN). While useful for surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed as having a UTI). Despite continuing progress in standard methods of reducing infection rates (including decreasing the number of catheters inserted, ensuring proper catheter maintenance, and removing catheters when no long necessary) there continue to be unacceptably high rates of CAUTIs.

A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is preferable to an antibacterial for preventing further antimicrobial resistance development. Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of removal, is potentially preferable from the downstream standpoint of less antimicrobial resistance and reduced risk of Clostridium difficile infection.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arm parallel study with 1 to 1 randomization
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal to Reduce Bacteriuria and Catheter-Associated Urinary Tract Infections
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Povidone-Iodine Irrigation
Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
Drug: Povidone-iodine irrigation
Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Other Name: Betadine

No Intervention: Standard of Care
Catheter removal with no bladder irrigation



Primary Outcome Measures :
  1. Diagnosis of Urinary Tract Infection (UTI) [ Time Frame: 48-72 hours after catheter removal ]
    Per NHSN defined catheter associated UTI (CAUTI) criteria


Secondary Outcome Measures :
  1. Diagnosis of UTI at 7 Days [ Time Frame: 7 days after catheter removal ]
    Per National Healthcare Safety Network (NHSN) defined CAUTI criteria

  2. Diagnosis of UTI at 28 Days [ Time Frame: 28 days after catheter removal ]
    Per NHSN defined CAUTI criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
  2. Male
  3. Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal

Exclusion Criteria:

  1. Patients planned for discharge with an indwelling catheter in place
  2. Patients unable to report urinary symptoms accurately
  3. Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
  4. Clinical signs or symptoms of urinary tract infection at the time of consent
  5. Patients currently being treated for UTI
  6. Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
  7. Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
  8. Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
  9. Patients unable to comply with study requirements
  10. Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data

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): NCT03447639


Locations
Layout table for location information
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Jay Hollander, MD William Beaumont Hospitals
  Study Documents (Full-Text)

Documents provided by Jay Hollander MD, William Beaumont Hospitals:
Informed Consent Form  [PDF] August 2, 2018


Layout table for additonal information
Responsible Party: Jay Hollander MD, Attending Urologist, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03447639     History of Changes
Other Study ID Numbers: 2018-001
First Posted: February 27, 2018    Key Record Dates
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: Yes
Keywords provided by Jay Hollander MD, William Beaumont Hospitals:
Catheter associated UTI
Povidine iodine
Bladder Irrigation
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Bacteremia
Catheter-Related Infections
Urologic Diseases
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
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