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NCT02929160 Clinical Trial

Percutaneous Nephrostomy Versus Stent In Sepsis Trial

Sepsis Clinical Trial

— PERSIST  

Official title:
Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02929160
Other study ID # AMNCH-GU-2016-1
Secondary ID 2016-004022-41
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 2020

Study information
Verified date September 2022
Source The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ureteric calculus with proximal hydronephrosis confirmed on CT KUB - White cell count >12,000mm3 and/or temperature >38C Exclusion Criteria: - Uncorrected coagulopathy - Urethral or ureteric stricture disease - Urinary diversion - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous nephrostomy
Percutaneous nephrostomy tube insertion under radiological guidance
• Retrograde ureteric JJ stent
Retrograde ureteric JJ stent insertion using cystoscopy

Locations
Country Name City State
Ireland St. James's Hospital Dublin
Ireland The Adelaide and Meath Hospital, incorporating The National Children's Hospital Tallaght Dublin

Sponsors (1)
Lead Sponsor Collaborator
The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to normalisation of white cell count and/or temperature Within 1 week
Secondary Length of hospital stay Within 1 week
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