跳至主要内容
临床试验/NCT02929160
NCT02929160撤回不适用

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

The Adelaide and Meath Hospital, incorporating The National Children's Hospital2 个研究点 分布在 1 个国家开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Time to normalisation of white cell count and/or temperature

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
  • White cell count >12,000mm3 and/or temperature >38C

排除标准

  • Uncorrected coagulopathy
  • Urethral or ureteric stricture disease
  • Urinary diversion
  • Pregnancy

结局指标

主要结局

Time to normalisation of white cell count and/or temperature

时间窗: Within 1 week

次要结局

  • Length of hospital stay(Within 1 week)

研究者

发起方
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rustom P Manecksha, MD, FRCS (Urol.)

Consultant Urologist

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

研究点 (2)

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