Early or Late Foley Removal After Thoracotomy

Urinary Tract Infections Clinical Trial

Official title:

Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611519
• Other study ID #: 11-006618
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: September 12, 2016
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: September 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for insertion of catheter after Foley removed.		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Development of urinary tract infection		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No