Early Versus Standard Urethral Catheter Removal After Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Thirty-day urinary tract infection
研究概览
简要总结
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.
详细描述
For ClinicalTrials.gov, the **Detailed Description** should be scientific and comprehensive, but not written like the introduction of a manuscript. It should explain the rationale, study design, intervention, and outcomes in language understandable to both clinicians and the public.
I would recommend the following:
# 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Undergoing living donor kidney transplantation
- •Pre-emptive kidney transplantation
- •Preserved urine output
- •Ability to provide written informed consent
排除标准
- •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
研究组 & 干预措施
Early Catheter Removal
Urethral catheter removal on postoperative day 3 (72 ± 6 hours).
干预措施: Early urethral catheter removal (Procedure)
Standard Catheter Removal
Urethral catheter removal on postoperative day 6 (144 ± 12 hours).
干预措施: Standard urethral catheter removal (Procedure)
结局指标
主要结局
Thirty-day urinary tract infection
时间窗: 30 days after transplantation
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
次要结局
- 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))
研究者
Fahim Kanani
MD - assistent professor
Rabin Medical Center
