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Early vs Late Urinary Catheter Removal After Renal Transplantation (ELUCATR)

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ClinicalTrials.gov Identifier: NCT04815954
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
PAWEŁ STUDNICKI, Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Kidney Transplant Infection Urinary Fistula Urinary Tract Infections Urinary Catheter Procedure: Urinary catheter removal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Early vs Late Urinary Catheter Removal After Renal Transplantation Randomised Clinical Trial
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : March 26, 2025
Estimated Study Completion Date : April 26, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early group
Early urinary catheter removal: 24±6 hours after completion of surgery.
Procedure: Urinary catheter removal
Removal of urinary catheter which was placed during kidney transplantation.

Active Comparator: Delayed group
Delayed urinary catheter removal: 72±6 hours after completion of surgery.
Procedure: Urinary catheter removal
Removal of urinary catheter which was placed during kidney transplantation.




Primary Outcome Measures :
  1. Urinary fistula [ Time Frame: 1 year ]
    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.

  2. Urinary stenosis [ Time Frame: 1 year ]
    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.

  3. 30 day graft function measured as serum creatinine [ Time Frame: 30 days ]
    Serum creatinine in mg/dl

  4. 1 year graft survival in days and function measured as serum creatinine [ Time Frame: 1 year ]
    Graft survival in days; serum creatinine in mg/dl


Secondary Outcome Measures :
  1. Urinary tract infections [ Time Frame: 1 year ]
    1. asymptomatic bacteriuria defined by the presence of >10^5 bacterial colony forming units per milliliter (CFU/mL) of urine on urine culture with no local or systemic symptoms of UTI,
    2. simple cystitis with the presence of >10^5 CFU/mL on urine culture with local urinary symptoms, such as dysuria, frequency, or urgency, but no systemic symptoms, such as fever or allograft pain,
    3. complicated UTI with the presence of >10^5 CFU/mL on urine culture with fever and allograft pain, chills, malaise or bacteremia with the same organism in urine, or biopsy with findings consistent with pyelonephritis,
    4. recurrent UTI with three or more episodes of UTI in one year

  2. BK virus infection [ Time Frame: 1 year ]
    Diagnosed with histopathology and positive immunohistochemistry staining for BK SV40 T antigen; in highly suspicious clinical cases prolonged (>2 weeks) urinary viral shedding with significant BK load (>10 000 copies/ mL) as presumptive diagnosis is also acceptable.

  3. Length of hospital stay [ Time Frame: 1 year ]
    Length of hispital stay in days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815954


Contacts
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Contact: Paweł Studnicki, MD +48886596284 pawelstudnicki@outlook.com
Contact: Maciej Kosieradzki, PHD +48225021784 mpkosieradzki@gmail.com

Locations
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Poland
Department of General and Transplantation Surgery Recruiting
Warszawa, Poland, 02-014
Contact: Maciej Kosieradzki, phd    +48225021784    mpkosieradzki@gmail.com   
Contact: Paweł Studnicki, md    +48886596284    pawelstudnicki@outlook.com   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Paweł Studnicki, MD Department of General and Transplantation Surgery, Medical University of Warsaw
Publications:

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Responsible Party: PAWEŁ STUDNICKI, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT04815954    
Other Study ID Numbers: Not assigned
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PAWEŁ STUDNICKI, Medical University of Warsaw:
kidney transplant
urinary tract infections
foley catheter
urinary catheter
urinary fistula
urethral stricture
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urinary Fistula
Fistula
Pathological Conditions, Anatomical
Urologic Diseases
Urogenital Abnormalities