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Percutaneous Nephrostomy Versus Stent In Sepsis Trial (PERSIST)

T

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Status

Withdrawn

Conditions

Hydronephrosis
Sepsis
Ureteric Calculus

Treatments

Procedure: Percutaneous nephrostomy
Procedure: Retrograde ureteric JJ stent

Study type

Interventional

Funder types

Other

Identifiers

NCT02929160
2016-004022-41 (EudraCT Number)
AMNCH-GU-2016-1

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

PCN
Experimental group
Description:
Percutaneous nephrostomy
Treatment:
Procedure: Percutaneous nephrostomy
JJ Stent
Experimental group
Description:
Retrograde ureteric JJ stent
Treatment:
Procedure: Retrograde ureteric JJ stent

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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