Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04815954
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2020-02-10
Brief Title:
Early vs Late Urinary Catheter Removal After Renal Transplantation
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Early vs Late Urinary Catheter Removal After Renal Transplantation Randomised Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELUCATR
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 31 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
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 31 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
21 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 11 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
22 Study design
Donor and pre-transplant recipient data will be noted in a database Donor blood urine and preservation solution will be cultured 105 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 surgeons 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
23 Eligibility and exclusion criteria
231 Inclusion criteria
Age18
Kidney transplant recipient
Informed consent signed
232 Exclusion criteria BMI18 or 40 kgm2 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 246 hours after surgery In a delayed group catheter will be removed 726 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 mlday If clear discharge 100 mlday 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 surgeons 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
24 Sample size and statistics
The investigators assumed early catheter removal reduces the risk of UTI by 10 RR09 and risk of urinary anastomosis complications is comparable To achieve a power of 80 at p005 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
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
21 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 11 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
22 Study design
Donor and pre-transplant recipient data will be noted in a database Donor blood urine and preservation solution will be cultured 105 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 surgeons 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
23 Eligibility and exclusion criteria
231 Inclusion criteria
Age18
Kidney transplant recipient
Informed consent signed
232 Exclusion criteria BMI18 or 40 kgm2 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 246 hours after surgery In a delayed group catheter will be removed 726 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 mlday If clear discharge 100 mlday 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 surgeons 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
24 Sample size and statistics
The investigators assumed early catheter removal reduces the risk of UTI by 10 RR09 and risk of urinary anastomosis complications is comparable To achieve a power of 80 at p005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None