Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 10, 2020
First Posted Date  ICMJE March 25, 2021
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE March 26, 2019
Estimated Primary Completion Date March 26, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • 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.
  • 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.
  • 30 day graft function measured as serum creatinine [ Time Frame: 30 days ]
    Serum creatinine in mg/dl
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • 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
  • 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.
  • Length of hospital stay [ Time Frame: 1 year ]
    Length of hispital stay in days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early vs Late Urinary Catheter Removal After Renal Transplantation
Official Title  ICMJE Early vs Late Urinary Catheter Removal After Renal Transplantation Randomised Clinical Trial
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.

Detailed Description
  1. Objectives of the study

    1. Main aim of the study:

      Early urinary catheter removal is safe and does not increase urinary complications rate. Zero hypothesis is that early and delayed Foley catheter removal have similar urinary complications rate (urinary fistula, urinary tract infections). Alternative hypothesis is that early catheter removal decreases urinary tract infections.

    2. Primary endpoints:

      • Urinary fistula or stenosis requiring intervention,
      • 30 day graft function measured as serum creatinine,
      • 1 year graft survival and function.
    3. Secondary endpoints:

      • Urinary tract infections,
      • BK virus infection,
      • length of hospital stay.
  2. Patients and Methods

2.1 Study organisation

The study has been designed as a randomized, controlled, open label, multicenter trial to compare urinary complications rate between early and delayed Foley catheter removal groups in kidney transplant recipients. Computer list of random numbers will be generated, even numbers will be assigned to early and odd numbers to late catheter removal, 1:1 randomisation ratio is expected. At least 3 large-volume renal transplant centers will participate in the study. 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. A record of computer-generated number and envelope number will be stored at the leader center. An institutional review board of the Medical University of Warsaw accepted the study design and patient information leaflet. MS Access-based electronic case report file will be used. CRFs will be checked for completeness and concordance with source documents and adherence to the study protocol by the study leader.

2.2 Study design

Donor and pre-transplant recipient data will be noted in a database. Donor blood, urine and preservation solution will be cultured, 10^5 colonies in the former is considered significant. Important transplant anatomical features, like multiple renal arteries will be noted. After screening and informed consent of the patient for participation in the study, kidney transplantation will be performed. Single dose of cefazolin adjusted for patient weight will be administered 30 minutes prior to skin incision. Other options of antibiotic prophylaxis or preemptive treatment are acceptable, however agent and duration must be noted in an electronic Case Report File (CRF). At the beginning of surgical procedure in the operating room, sterile catheterization of the urinary bladder and microbiology sampling will be performed. After uneventful vascular anastomosis, neoureterocystostomy will be done with Lich-Gregoire or a variation of U-stitch technique (McKinnon, other typical). Ureteral stent will be placed at surgeon's discretion. Suction drainage will be positioned in graft proximity. After wound closure and completion of the surgery, inclusion and exclusion criteria will be evaluated. Intraoperative data (blood loss, surgery duration, cold ischemia time, details of the anastomosis, utilization of magnifying loupes, pigtail placement) will be noted.

2.3 Eligibility and exclusion criteria.

2.3.1 Inclusion criteria

  • Age>18
  • Kidney transplant recipient
  • Informed consent signed

2.3.2 Exclusion criteria BMI<18 or >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 Haemodynamic shock or profund instability after surgery

Participants will be randomised to a group early urinary catheter removal (EG) or delayed removal group (DG). Early catheter removal will be done 24±6 hours after surgery. In a delayed group catheter will be removed 72±6 hours after completion of surgery. Shorter or longer catheterization will be considered protocol violation and reasons for ought to be explained in source documents and CRF.

Suction drain will be removed when discharge volume falls below 50 ml/day. If clear discharge (>100 ml/day) continues for 2 consecutive days, discharge fluid and serum creatinine ought to be measured. If fluid creatinine exceeds its serum concentration by at least 30%, urine leakage will be diagnosed and appropriate intervention applied according to surgeon's clinical judgement. Only fistulas requiring medical intervention: reintroduction of the catheter, endoscopic stenting, nephrostomy or surgery will be considered significant and fulfill criteria for primary endpoint of the study.

The course of study will consist of screen visit, hospitalization (with the transplantation procedure, catheter removal, follow up after 48h after catheter removal), follow up visit at 15 days after procedure and follow up visit at 30 days after procedure (see table 2). Patients with urinary complications (fistula, stenosis, infection) will have additional visits every 30 days until complete resolution of complication. Patients with stented anastomosis who will not have a pigtail removed until day 30 will be followed till 7 days after stent removal or resolution of complications would any occur. A final visit 1 year after transplantation will assess patient and graft survival, kidney function, late urinary complications beyond one month from transplantation.

2.4 Sample size and statistics

The investigators assumed early catheter removal reduces the risk of UTI by 10% (RR=0.9) and risk of urinary anastomosis complications is comparable. To achieve a power of 80% at p=0,05 an expected sample size is 450 patients divided fairly into 2 groups. An intent-to-treat analysis will be performed. Graft survival analysis and length of hospital stay will be calculated with log-rank test. Renal function will be analysed with Student t test, provided normal distribution of serum creatinine is observed. Chi2 will be used for analysis of urinary complications. Post hoc analysis of donor and recipient entry data will confirm groups being comparable fo UTI and urinary fistula risk factors.

Subgroup analysis in groups with and without urinary stent will be performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Kidney Transplant; Complications
  • Kidney Transplant Infection
  • Urinary Fistula
  • Urinary Tract Infections
  • Urinary Catheter
Intervention  ICMJE Procedure: Urinary catheter removal
Removal of urinary catheter which was placed during kidney transplantation.
Study Arms  ICMJE
  • Experimental: Early group
    Early urinary catheter removal: 24±6 hours after completion of surgery.
    Intervention: Procedure: Urinary catheter removal
  • Active Comparator: Delayed group
    Delayed urinary catheter removal: 72±6 hours after completion of surgery.
    Intervention: Procedure: Urinary catheter removal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2021)
450
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
54
Estimated Study Completion Date  ICMJE April 26, 2026
Estimated Primary Completion Date March 26, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paweł Studnicki, MD +48886596284 pawelstudnicki@outlook.com
Contact: Maciej Kosieradzki, PHD +48225021784 mpkosieradzki@gmail.com
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04815954
Other Study ID Numbers  ICMJE Not assigned
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PAWEŁ STUDNICKI, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paweł Studnicki, MD Department of General and Transplantation Surgery, Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP