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Percutaneous Nephrostomy Versus Stent In Sepsis Trial (PERSIST)

Primary Purpose

Ureteric Calculus, Sepsis, Hydronephrosis

Status
Withdrawn
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Percutaneous nephrostomy
Retrograde ureteric JJ stent
Sponsored by
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteric Calculus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Adelaide and Meath Hospital, incorporating The National Children's Hospital
  • St. James's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PCN

JJ Stent

Arm Description

Percutaneous nephrostomy

Retrograde ureteric JJ stent

Outcomes

Primary Outcome Measures

Time to normalisation of white cell count and/or temperature

Secondary Outcome Measures

Length of hospital stay

Full Information

First Posted
October 7, 2016
Last Updated
September 24, 2022
Sponsor
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02929160
Brief Title
Percutaneous Nephrostomy Versus Stent In Sepsis Trial
Acronym
PERSIST
Official Title
Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Adelaide and Meath Hospital, incorporating The National Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Image-guided percutaneous nephrostomy tube placement 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteric Calculus, Sepsis, Hydronephrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCN
Arm Type
Experimental
Arm Description
Percutaneous nephrostomy
Arm Title
JJ Stent
Arm Type
Experimental
Arm Description
Retrograde ureteric JJ stent
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrostomy
Intervention Description
Percutaneous nephrostomy tube insertion under radiological guidance
Intervention Type
Procedure
Intervention Name(s)
Retrograde ureteric JJ stent
Intervention Description
Retrograde ureteric JJ stent insertion using cystoscopy
Primary Outcome Measure Information:
Title
Time to normalisation of white cell count and/or temperature
Time Frame
Within 1 week
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Within 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
City
Tallaght
State/Province
Dublin
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Percutaneous Nephrostomy Versus Stent In Sepsis Trial

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