Percutaneous Nephrostomy Versus Stent In Sepsis Trial (PERSIST)

September 24, 2022 updated by: Rustom P Manecksha, MD, FRCS (Urol.), The Adelaide and Meath Hospital, incorporating The National Children's Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCN
Percutaneous nephrostomy
Procedure: Percutaneous nephrostomy
Percutaneous nephrostomy tube insertion under radiological guidance
Experimental: JJ Stent
Retrograde ureteric JJ stent
Procedure: Retrograde ureteric JJ stent
Retrograde ureteric JJ stent insertion using cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to normalisation of white cell count and/or temperature
Time Frame: Within 1 week
Within 1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Within 1 week
Within 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 24, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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