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强制利尿对输尿管软镜激光破坏肾结石后残留碎片率的影响：随机对照两平行组多中心盲法评估试验 (FIREStones)

2026年11月4日 更新者：University Hospital, Tours

FIRESTONES：强制利尿对输尿管软镜激光破坏肾结石后残留碎片率的影响：随机对照两平行组多中心试验，盲法评估

In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Flexible ureteroscopy is the most common technique to treat kidney stones and is the treatment of choice in France.

Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created during stone destruction cannot be extracted using our surgical tools, and may stay intra-renally at the end of the procedure. Although these micro-fragments are expected to disappear spontaneously by the natural flushing and peristalsis of the upper urinary tract, they remain at risk of stagnation that could be the nest of new aggregation and stone formation.

Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy.

Nevertheless, the impact of adjuvant treatment after flexible ureteroscopy remains unclear and mainly theoretical.

In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.

Loop diuretics (including Furosemide) significantly increase diuresis, which results in a greater flow of urine into the renal cavities, improving the chances of evacuating the residual fragments of the stone destroyed during flexible ureteroscopy, before they can sediment in the fundus of the renal calices or in the pyelon. Therefore, the investigators hypothesize that a forced diuresis with an injection of Furosemide at the end of ureteroscopy could improve the micro-fragments and stones dust clearance.

研究类型

介入性

注册 (估计的)

374

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Angers、法国
        • 招聘中
        • CHU d'Angers
        • 接触：
        • 首席研究员：
          • Pierre BIGOT
      • Lyon、法国
        • 招聘中
        • Hospices Civils de Lyon
        • 接触：
        • 首席研究员：
          • Nadia ABID
      • Nice、法国
        • 招聘中
        • CHU de Nice
        • 接触：
        • 首席研究员：
          • Mathieu DURAND
      • Nîmes、法国
        • 招聘中
        • CHU de Nîmes
        • 接触：
        • 首席研究员：
          • Stéphane DROUPY
      • Rennes、法国
      • Rouen、法国
        • 招聘中
        • CHU de Rouen
        • 接触：
        • 首席研究员：
          • Hugo DUPUIS
      • Toulouse、法国
        • 招聘中
        • CHU de Toulouse
        • 首席研究员：
          • Xavier GAME
        • 接触：
      • Toulouse、法国
        • 招聘中
        • Clinique La Croix du Sud
        • 接触：
        • 首席研究员：
          • Christophe ALMERAS
      • Tours、法国
        • 招聘中
        • CHRU de Tours
        • 接触：
        • 首席研究员：
          • Marie-Lou LETOUCHE

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients ≥ 18 years old and < 80 years old
  • With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
  • Participants covered by or entitled to social security
  • Written informed consent obtained from the participant
  • Ability for participant to comply with the requirements of the study

Exclusion Criteria:

  • Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)

  • Contra-indication to Furosemide:

    • Hyper-sensitivity to the active substance or one of the excipients
    • Hyper-sensitivity to Sulfonamide
    • Renal failure with oligo-anuria refractory to Furosemide
    • Hypokalemia < 3,5 mmol/L
    • Severe hyponatremia
    • Hypovolemia with or without hypotension or dehydration
    • Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy

  • Patient having Furosemide as usual treatment

  • Patient requiring an injection of Aminoside or Vancomycin before or during the procedure

  • Participation in other interventional research with an investigational drug or medical device

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Furosemide

Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
药品：Furosemide 40 mg

Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.
无干预：Usual care

Usual care, without injection of Furosemide.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of stone free patients
大体时间：At 3 months

Rate of stone-free patients 3 months after a flexible ureteroscopy for renal stone laser destruction, evaluated on the low dose abdomino-pelvic CT-Scan.

A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results
At 3 months

次要结果测量

结果测量
措施说明
大体时间
Rate of urinary infection
大体时间：From baseline to 30 days

Rate of post-operative urinary tract infection will be assessed within 30 days after surgery on the combination of:

  • Fever higher than 38.5°C and/or,
  • Chills and/or,
  • Clinical symptoms (supra-pubic pain, dysuria, pollakiuria, urgency, urinary burning, back pain radiating to the genitals, hematuria) and/or
  • Positive urine culture with a significant bacteriuria threshold defined as bacteriuria ≥10^5 UFC/mL with one or two bacterial species.
From baseline to 30 days
Pain in a scale
大体时间：During the hospital stay

Post-operative pain will be assessed on numerical pain scale in the recovery room, in the service and at the discharge. Pain scale is from 0 (no pain) to 10 (as bad as it could be nothing else matters)
During the hospital stay
Opioid consumption
大体时间：During the hospital stay, an average of 1 day

The use of opioids will be reported
During the hospital stay, an average of 1 day
Number of participants with adverse events
大体时间：From baseline to 3 months, an average of 1 day

Number of participants with Furosemide adverse events
From baseline to 3 months, an average of 1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Tours

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月4日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2023年6月14日

首先提交符合 QC 标准的

2023年6月14日

首次发布 (实际的)

2023年6月23日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2022-502890-40-00
  • DR220258 (其他标识符：Promoter reference)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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