Percutaneous Nephrostomy Versus Stent In Sepsis Trial

Not Applicable

Withdrawn

• Conditions: Ureteric Calculus; Sepsis; Hydronephrosis
• Interventions: Procedure: Retrograde ureteric JJ stent; Procedure: Percutaneous nephrostomy

• Registration Number: NCT02929160
• Lead Sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-11
• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JJ Stent	Retrograde ureteric JJ stent	Retrograde ureteric JJ stent
PCN	Percutaneous nephrostomy	Percutaneous nephrostomy

Primary Outcome Measures

Name	Time	Method
Time to normalisation of white cell count and/or temperature	Within 1 week

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Within 1 week

Trial Locations

Locations (2)

St. James's Hospital; 🇮🇪 Dublin, Ireland

The Adelaide and Meath Hospital, incorporating The National Children's Hospital; 🇮🇪 Tallaght, Dublin, Ireland