Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-04-21 @ 8:38 PM
Study NCT ID:
NCT02929160
Status:
WITHDRAWN
Last Update Posted:
2022-09-27
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Nephrostomy Versus Stent In Sepsis Trial
Sponsor:
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Organization:
Study Overview
Official Title:
Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial
Status:
WITHDRAWN
Status Verified Date:
2022-09
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:
PERSIST
Brief Summary:
Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
Detailed Description:
The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted.
There are two options for urgent decompression of an obstructed collecting system:
1. Image-guided percutaneous nephrostomy tube placement
2. Cystoscopic retrograde placement of a ureteric stent
This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.
Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.
This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
There are two options for urgent decompression of an obstructed collecting system:
1. Image-guided percutaneous nephrostomy tube placement
2. Cystoscopic retrograde placement of a ureteric stent
This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.
Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.
This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-004022-41 | EUDRACT_NUMBER | None | View |