Kidney Transplant; ComplicationsELUCATRNCT04815954
Early vs Late Urinary Catheter Removal After Renal Transplantation
A study testing Urinary catheter removal in people with Kidney Transplant; Complications and Kidney Transplant Infection, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Kidney Transplant Infection, Urinary Fistula
- What is being tested?
- Urinary catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 26 Mar 2019to 26 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipient
- Informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early vs Late Urinary Catheter Removal After Renal Transplantation Randomised Clinical Trial
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.
Read more
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.
Read the detailed description
- Objectives of the study
- 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.
- Primary endpoints:
- Urinary fistula or stenosis requiring intervention,
- 30 day graft function measured as serum creatinine,
- 1 year graft survival and function.
- Secondary endpoints:
- Urinary tract infections,
- BK virus infection,
- length of hospital stay.
- 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.
- Conditions
- Kidney Transplant; Complications, Kidney Transplant Infection, Urinary Fistula, Urinary Tract Infections, Urinary Catheter
- Being tested
- Urinary catheter removal
- Keywords
- kidney transplant, urinary tract infections, foley catheter, urinary catheter, urinary fistula, urethral stricture
- Medical subject headings
- Urinary Fistula, Urinary Tract Infections, Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary catheter removalProcedure or surgery
Removal of urinary catheter which was placed during kidney transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Early group | Experimental | Early urinary catheter removal: 24±6 hours after completion of surgery. Receives: Procedure: Urinary catheter removal |
| Delayed group | Active comparator | Delayed urinary catheter removal: 72±6 hours after completion of surgery. Receives: Procedure: Urinary catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
30 day graft function measured as serum creatinine
Serum creatinine in mg/dl
Measured: 30 days
1 year graft survival in days and function measured as serum creatinine
Graft survival in days; serum creatinine in mg/dl
Measured: 1 year
Secondary outcomes (3)
Urinary tract infections
- 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,
- 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,
- 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,
- recurrent UTI with three or more episodes of UTI in one year
Measured: 1 year
BK virus infection
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.
Measured: 1 year
Length of hospital stay
Length of hispital stay in days.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start26 Mar 2019
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAWEŁ STUDNICKI, Medical University of Warsaw
- Investigators
- Paweł Studnicki, MD, Principal investigator, Department of General and Transplantation Surgery, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815954
- Sponsor's protocol ID
- Not assigned
- Acronym
- ELUCATR
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2020
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brar S, Wang Y, Cannitelli A, Lambadaris M, Li Y, Famure O, Husain S, Kim SJ. Bacteremia in kidney transplant recipients: Burden, causes, and consequences. Clin Transplant. 2019 Mar;33(3):e13479. doi: 10.1111/ctr.13479. Epub 2019 Feb 8.
PubMed 30650217Goldman JD, Julian K. Urinary tract infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13507. doi: 10.1111/ctr.13507. Epub 2019 Mar 28.
PubMed 30793386Akbari R, Rahmani Firouzi S, Akbarzadeh-Pasha A. Old habits die hard; does early urinary catheter removal affect kidney size, bacteriuria and UTI after renal transplantation? J Renal Inj Prev. 2016 Nov 20;6(1):43-48. doi: 10.15171/jrip.2017.08. eCollection 2017.
PubMed 28487871Cole T, Hakim J, Shapiro R, Kayler LK. Early urethral (Foley) catheter removal positively affects length of stay after renal transplantation. Transplantation. 2007 Apr 15;83(7):995-6. doi: 10.1097/01.tp.0000259723.92943.8f. No abstract available.
PubMed 17460573Chuang P, Parikh CR, Langone A. Urinary tract infections after renal transplantation: a retrospective review at two US transplant centers. Clin Transplant. 2005 Apr;19(2):230-5. doi: 10.1111/j.1399-0012.2005.00327.x.
PubMed 15740560Lempinen M, Stenman J, Kyllonen L, Salmela K. Surgical complications following 1670 consecutive adult renal transplantations: A single center study. Scand J Surg. 2015 Dec;104(4):254-9. doi: 10.1177/1457496914565419. Epub 2015 Jan 7.
PubMed 25567856Siskind E, Sameyah E, Goncharuk E, Olsen EM, Feldman J, Giovinazzo K, Blum M, Tyrell R, Evans C, Kuncewitch M, Alexander M, Israel E, Bhaskaran M, Calderon K, Jhaveri KD, Sachdeva M, Bellucci A, Mattana J, Fishbane S, D'Agostino C, Coppa G, Molmenti E. Removal of foley catheters in live donor kidney transplant recipients on postoperative day 1 does not increase the incidence of urine leaks. Int J Angiol. 2013 Mar;22(1):45-8. doi: 10.1055/s-0033-1333870.
PubMed 24436583Abramowicz D, Cochat P, Claas FH, Heemann U, Pascual J, Dudley C, Harden P, Hourmant M, Maggiore U, Salvadori M, Spasovski G, Squifflet JP, Steiger J, Torres A, Viklicky O, Zeier M, Vanholder R, Van Biesen W, Nagler E. European Renal Best Practice Guideline on kidney donor and recipient evaluation and perioperative care. Nephrol Dial Transplant. 2015 Nov;30(11):1790-7. doi: 10.1093/ndt/gfu216. Epub 2014 Jul 9.
PubMed 25007790Menegueti MG, Pereira MF, Bellissimo-Rodrigues F, Garcia TM, Saber LT, Nardim ME, Muglia VA, Neto MM, Romao EA. Study of the risk factors related to acquisition of urinary tract infections in patients submitted to renal transplant. Rev Soc Bras Med Trop. 2015 May-Jun;48(3):285-90. doi: 10.1590/0037-8682-0098-2015.
PubMed 26108006Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.
PubMed 8394951Wilson CH, Rix DA, Manas DM. Routine intraoperative ureteric stenting for kidney transplant recipients. Cochrane Database Syst Rev. 2013 Jun 17;(6):CD004925. doi: 10.1002/14651858.CD004925.pub3.
PubMed 23771708de Souza RM, Olsburgh J. Urinary tract infection in the renal transplant patient. Nat Clin Pract Nephrol. 2008 May;4(5):252-64. doi: 10.1038/ncpneph0781. Epub 2008 Mar 11.
PubMed 18334970Ariza-Heredia EJ, Beam EN, Lesnick TG, Cosio FG, Kremers WK, Razonable RR. Impact of urinary tract infection on allograft function after kidney transplantation. Clin Transplant. 2014 Jun;28(6):683-90. doi: 10.1111/ctr.12366. Epub 2014 Apr 27.
PubMed 24654771Adamska Z, Karczewski M, Cichanska L, Wieckowska B, Malkiewicz T, Mahadea D, Stronka M. Bacterial Infections in Renal Transplant Recipients. Transplant Proc. 2015 Jul-Aug;47(6):1808-12. doi: 10.1016/j.transproceed.2015.03.046.
PubMed 26293055Ak O, Yildirim M, Kucuk HF, Gencer S, Demir T. Infections in renal transplant patients: risk factors and infectious agents. Transplant Proc. 2013 Apr;45(3):944-8. doi: 10.1016/j.transproceed.2013.02.080.
PubMed 23622594
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs Late Urinary Catheter Removal After Renal Transplantation Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04815954
- Acronym / sponsor ID
- ELUCATR / Not assigned
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Objectives of the study
- 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.
- Primary endpoints:
- Urinary fistula or stenosis requiring intervention,
- 30 day graft function measured as serum creatinine,
- 1 year graft survival and function.
- Secondary endpoints:
- Urinary tract infections,
- BK virus infection,
- length of hospital stay.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early group | Experimental | Procedure: Urinary catheter removalEarly urinary catheter removal: 24±6 hours after completion of surgery. |
| Delayed group | Active comparator | Procedure: Urinary catheter removalDelayed urinary catheter removal: 72±6 hours after completion of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney transplant recipient
- Informed consent signed
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary catheter removalRemoval of urinary catheter which was placed during kidney transplantation. | Procedure or surgery | Delayed group, Early group |
Primary outcome
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
3 secondary outcomes
Urinary tract infections
Time frame: 1 year
BK virus infection
Time frame: 1 year
Length of hospital stay
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 30650217Brar S, Wang Y, Cannitelli A, Lambadaris M, Li Y, Famure O, Husain S, Kim SJ. Bacteremia in kidney transplant recipients: Burden, causes, and consequences. Clin Transplant. 2019 Mar;33(3):e13479. doi: 10.1111/ctr.13479. Epub 2019 Feb 8.
- Background: PubMed 30793386Goldman JD, Julian K. Urinary tract infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13507. doi: 10.1111/ctr.13507. Epub 2019 Mar 28.
- Background: PubMed 28487871Akbari R, Rahmani Firouzi S, Akbarzadeh-Pasha A. Old habits die hard; does early urinary catheter removal affect kidney size, bacteriuria and UTI after renal transplantation? J Renal Inj Prev. 2016 Nov 20;6(1):43-48. doi: 10.15171/jrip.2017.08. eCollection 2017.
- Background: PubMed 17460573Cole T, Hakim J, Shapiro R, Kayler LK. Early urethral (Foley) catheter removal positively affects length of stay after renal transplantation. Transplantation. 2007 Apr 15;83(7):995-6. doi: 10.1097/01.tp.0000259723.92943.8f. No abstract available.
- Background: PubMed 15740560Chuang P, Parikh CR, Langone A. Urinary tract infections after renal transplantation: a retrospective review at two US transplant centers. Clin Transplant. 2005 Apr;19(2):230-5. doi: 10.1111/j.1399-0012.2005.00327.x.
- Background: PubMed 25567856Lempinen M, Stenman J, Kyllonen L, Salmela K. Surgical complications following 1670 consecutive adult renal transplantations: A single center study. Scand J Surg. 2015 Dec;104(4):254-9. doi: 10.1177/1457496914565419. Epub 2015 Jan 7.
- Background: PubMed 24436583Siskind E, Sameyah E, Goncharuk E, Olsen EM, Feldman J, Giovinazzo K, Blum M, Tyrell R, Evans C, Kuncewitch M, Alexander M, Israel E, Bhaskaran M, Calderon K, Jhaveri KD, Sachdeva M, Bellucci A, Mattana J, Fishbane S, D'Agostino C, Coppa G, Molmenti E. Removal of foley catheters in live donor kidney transplant recipients on postoperative day 1 does not increase the incidence of urine leaks. Int J Angiol. 2013 Mar;22(1):45-8. doi: 10.1055/s-0033-1333870.
- Background: PubMed 25007790Abramowicz D, Cochat P, Claas FH, Heemann U, Pascual J, Dudley C, Harden P, Hourmant M, Maggiore U, Salvadori M, Spasovski G, Squifflet JP, Steiger J, Torres A, Viklicky O, Zeier M, Vanholder R, Van Biesen W, Nagler E. European Renal Best Practice Guideline on kidney donor and recipient evaluation and perioperative care. Nephrol Dial Transplant. 2015 Nov;30(11):1790-7. doi: 10.1093/ndt/gfu216. Epub 2014 Jul 9.
- Background: PubMed 26108006Menegueti MG, Pereira MF, Bellissimo-Rodrigues F, Garcia TM, Saber LT, Nardim ME, Muglia VA, Neto MM, Romao EA. Study of the risk factors related to acquisition of urinary tract infections in patients submitted to renal transplant. Rev Soc Bras Med Trop. 2015 May-Jun;48(3):285-90. doi: 10.1590/0037-8682-0098-2015.
- Background: PubMed 8394951Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.
- Background: PubMed 23771708Wilson CH, Rix DA, Manas DM. Routine intraoperative ureteric stenting for kidney transplant recipients. Cochrane Database Syst Rev. 2013 Jun 17;(6):CD004925. doi: 10.1002/14651858.CD004925.pub3.
- Background: PubMed 18334970de Souza RM, Olsburgh J. Urinary tract infection in the renal transplant patient. Nat Clin Pract Nephrol. 2008 May;4(5):252-64. doi: 10.1038/ncpneph0781. Epub 2008 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Studnicki, MD principal investigator
Department of General and Transplantation Surgery, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary catheter removal in people with Kidney Transplant; Complications and Kidney Transplant Infection, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary fistula (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815954, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.