Early vs Late Urinary Catheter Removal After Renal Transplantation

NCT04815954 | Active Not Recruiting

• 1 other identifier: Not assigned
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Complications; Kidney Transplant Infection; Urinary Fistula; Urinary Tract Infections; Urinary Catheter

Keywords

kidney transplant; urinary tract infections; foley catheter; urinary catheter; urinary fistula; urethral stricture

Outcome Measures

Primary Outcomes (4)

• Urinary fistula

  Presence of urine in the drains or peri-transplant fluid collection demonstrated with biochemical analysis (creatinine in mg/dl in the drains or aspirate exceeding that of serum in mg/dl by at least 30%); symptoms may be present in the first week after transplantation as increased drainage discharge, impaired graft function and decreased diuresis, fluid collection seen in ultrasound, CT or scintigraphy, discharge onto the skin, abdominal pain, cutaneous oedema often towards the scrotum, pain and inflammatory appearance of the scar; volume of the discharge has no influence on diagnosis. Only fistulas requiring medical intervention as reintroduction of the catheter, endoscopic stenting, nephrostomy or surgery will be considered in the study.

  1 year

• Urinary stenosis

  Obstruction of the urine outflow from the transplanted kidney causing pelvicalyceal dilatation and impaired graft function; dilatation may be minimal due to fibrosis of the renal tissue and ex juvantibus diagnosis in these cases is acceptable. Only strictures requiring medical intervention as reintroduction of the catheter, endoscopic stenting, nephrostomy or surgery will be considered in the study.

  1 year

• 30 day graft function measured as serum creatinine

  Serum creatinine in mg/dl

  30 days

• 1 year graft survival in days and function measured as serum creatinine

  Graft survival in days; serum creatinine in mg/dl

  1 year

Secondary Outcomes (3)

• Urinary tract infections

  1 year

• BK virus infection

  1 year

• Length of hospital stay

  1 year

Study Arms (2)

Early group

EXPERIMENTAL

Early urinary catheter removal: 24±6 hours after completion of surgery.

Procedure: Urinary catheter removal

Delayed group

ACTIVE COMPARATOR

Delayed urinary catheter removal: 72±6 hours after completion of surgery.

Procedure: Urinary catheter removal

Interventions

Urinary catheter removal PROCEDURE

Removal of urinary catheter which was placed during kidney transplantation.

Delayed group; Early group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipient
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General and Transplantation Surgery

Warsaw, 02-014, Poland

Location

Related Publications (40)

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MeSH Terms

Conditions

Urinary Fistula; Urinary Tract Infections; Urethral Stricture

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Urologic Diseases; Urethral Obstruction; Urethral Diseases

Study Officials

• Paweł Studnicki, MD

  Department of General and Transplantation Surgery, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomisation will be supervised centrally by the leader center. Generated numbers will be closed in non-transparent envelopes numbered sequentially and shipped to each participating center. A center is supposed to use the envelopes for group assignment consecutively with increasing numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 25, 2021
• Study Start: March 26, 2019
• Primary Completion: March 26, 2026
• Study Completion (Estimated): April 26, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)