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Active Not Recruiting NCT04815954

Early vs Late Urinary Catheter Removal After Renal Transplantation

Conditions: Kidney Transplant; Complications, Kidney Transplant Infection, Urinary Fistula, Urinary Tract Infections, Urinary Catheter

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Medical University of Warsaw

Location: Department of General and Transplantation Surgery Warsaw

Summary

The purpose of this study is to compare frequency of UTI, urine leak and need for reoperation in patients after renal transplant with early or delayed Foley catheter removal. The hypothesis of the ELUCATR trial is that there is no need to keep Foley catheter longer than 24 hours after kidney transplant due to lack of significant effect on urological complications (urine leak, ureter strictures). Early removal can also reduce urinary tract infections. Main advantage of urinary catheter placement is continual diuresis monitoring and lower bladder pressure. Some hypothesize that increased pressure can disrupt ureteroneocystostomy with resultant urinary fistula. Clinical practice is to remove the catheter between 1-10 post-transplant day. Only few studies described removal of Foley catheter in the first 48 hours. There is no level 1 evidence for timing of urinary catheter removal after kidney transplantation. Urinary tract infection is a common complication after KTx occurring in about 7-80% patients. Studies suggest direct negative effect of UTI on long-term renal allograft function. There are several independent risk factors for developing UTI: female sex, diabetes and obesity. Duration of catheterization is a modifiable risk factor. Urine leak and ureter stenosis are relatively frequent surgical complications of kidney transplantation. Urine leaks occur in 2-9% of all kidney transplants. Most of them happen within 3 months after surgery. Urinary fistula contributes to mortality and graft loss. Majority of them need intervention with nephrostomy, pigtail ureteral stent or surgery. Anastomotic or ureter stenosis occurs in 3.1% of all kidney transplants and is usually resolved with open ureteroneocystostomy. Diagnosed and treated early, it does not affect patient and graft survival. There are no solid data documenting influence of the urinary bladder catheterization on fistulas, urinomas, ureter strictures and need for reoperation in this set of patients. European Best Renal Practice Guidelines recommend removal of the catheter as early as possible, however a randomized trial on timing and adverse event rates (urinary tract infection, urinary leakage) is needed.

Eligibility Criteria

Inclusion Criteria: * Kidney transplant recipient * Informed consent signed Exclusion Criteria: * BMI under 18kg/m2 * BMI over 40 kg/m2 * Significant anatomical abnormalities of lower urinary tract * Previous surgery on bladder or urinary tract * Unusual urinary anastomosis (Leadbetter-Politano, Boari, conduit, psoas hitch, pyelo-ureteral or uretero-ureteral, double ureter) * Severe vascular complications during surgery with blood loss \>1000 ml * Underwent haemodynamic shock or profund instability after surgery

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04815954). StuddyBuddy aggregates publicly available trial information.