Early Versus Standard Urethral Catheter Removal After Kidney Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Thirty-day urinary tract infection
Study Overview
Brief Summary
Urinary tract infection is one of the most common complications after kidney transplantation and is associated with increased morbidity, prolonged hospitalization, and impaired graft outcomes. The duration of urethral catheterization is a modifiable risk factor for catheter-associated urinary tract infection. This randomized controlled trial compares early catheter removal on postoperative day 3 with standard catheter removal on postoperative day 6 in living donor kidney transplant recipients. The primary objective is to determine whether early catheter removal reduces 30-day urinary tract infections without increasing urinary complications requiring intervention.
Detailed Description
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# Detailed Description
Urinary tract infection (UTI) is among the most frequent complications following kidney transplantation and remains a major source of postoperative morbidity. Catheter-associated urinary tract infections (CAUTIs) account for a substantial proportion of these infections because urethral catheterization is routinely performed after transplantation to protect the ureterovesical anastomosis, ensure continuous bladder drainage, and facilitate monitoring of urine output during the early postoperative period. However, prolonged catheterization increases the risk of bacterial colonization and infection, which may result in symptomatic UTI, pyelonephritis, bacteremia, prolonged hospitalization, increased healthcare costs, and potentially adverse graft outcomes.
The optimal duration of urethral catheterization after kidney transplantation remains uncertain. Current practice varies considerably among transplant centers, with catheter removal occurring anywhere from postoperative day (POD) 1 to POD 7 or later. This variation reflects the lack of high-quality randomized evidence balancing the potential benefits of earlier catheter removal against concerns regarding urinary retention, urinary leak, ureteral complications, and the need for catheter reinsertion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
The intervention cannot be blinded because catheter removal timing is apparent to participants and treating clinicians. Outcome assessment will be performed by investigators blinded to treatment allocation whenever feasible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Undergoing living donor kidney transplantation
- •Pre-emptive kidney transplantation
- •Preserved urine output
- •Ability to provide written informed consent
Exclusion Criteria
- •Previous bladder or urethral surgery
- •Complex urinary tract reconstruction
- •Neurogenic bladder
- •Active urinary tract infection at the time of transplantation
- •Pregnancy
- •Body mass index (BMI) <18 or >40 kg/m²
- •Intraoperative blood loss >1000 mL
Arms & Interventions
Early Catheter Removal
Urethral catheter removal on postoperative day 3 (72 ± 6 hours).
Intervention: Early urethral catheter removal (Procedure)
Standard Catheter Removal
Urethral catheter removal on postoperative day 6 (144 ± 12 hours).
Intervention: Standard urethral catheter removal (Procedure)
Outcomes
Primary Outcomes
Thirty-day urinary tract infection
Time Frame: 30 days after transplantation
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
Secondary Outcomes
- Urinary leak requiring intervention(30 days)
- Ureteral stenosis requiring intervention(12 months)
- Acute urinary retention requiring re-catheterization(5 days)
- Length of hospital stay(From transplantation until hospital discharge (approximately 30 days))
Investigators
Fahim Kanani
MD - assistent professor
Rabin Medical Center