Early or Late Foley Removal After Thoracotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Allen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01611519
First received: June 1, 2012
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

Condition
Urinary Tract Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Need for insertion of catheter after Foley removed. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of urinary tract infection [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: December 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Early (within 48 hours of surgery)
Patients will have their urinary catheter removed within 48 hours of surgery
Late (6 hours after epidural removal)
Patients will have their urinary catheter removed 6 hours after their epidural is removed

Detailed Description:
We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing thoracic surgery at the Mayo Clinic
Criteria

Inclusion Criteria:

  • epidural catheter after thoracic surgery
  • foley in place

Exclusion Criteria:

  • < 18 years of age
  • death in hospital within 30 days of the operation
  • length of hospital stay is less than 48 hours
  • epidural catheter is removed before the 3rd postoperative day
  • patients who have a suprapubic catheter or no bladder
  • patients who require a urologist or a urologic technician to insert the Foley catheter at the time of surgery
  • patients who were being intermittently catheterized before surgery
  • patients with a known urinary tract infection preoperatively
  • patients required to keep Foley in since they required close monitoring of urinary output
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611519

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Allen, MD Mayo Clinic
  More Information

Responsible Party: Mark Allen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01611519     History of Changes
Other Study ID Numbers: 11-006618 
Study First Received: June 1, 2012
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
urinary bladder
urinary catheterization
epidural analgesia
catheters, indwelling

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 21, 2016