2022-502890-40-00招募中3 期
FIRE Stones : Impact of Furosemide on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser : a controlled two-parallel group multicenter trial with blinding evaluation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 9
- 主要终点
- Stone-free rate at 3 months of 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
研究概览
简要总结
To show that the injection of 40 mg of Furosemide in slow intravenous during 10 minutes after the procedure, increases the stone-free rate 3 months after a flexible ureteroscopy for destruction of kidney stones with laser.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years old < 80 years old
- •With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
- •Person affiliated to a French social security system or equivalent
- •Written informed consent obtained from the participant
- •Ability for participant to comply with the requirements of the study
- •Stones of less than 3 cm
排除标准
- •Contra-indication to Furosemide: o Hyper-sensitivity to the active substance or one of the excipients o Hyper-sensitivity to Sulfonamide o Renal failure with oligo-anuria refractory to Furosemide o Hypokalemia < 3,5 mmol/L o Severe hyponatremia o Hypovolemia with or without hypotension or dehydration o 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
- •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)
- •Hepatic insufficiency due to the risk of hepatic encephalopathy
- •Hepatorenal syndrome
- •Hypoproteinemia especially in case of nephrotic syndrome
- •Drug-drug interactions with furosemide especially the lithium
结局指标
主要结局
Stone-free rate at 3 months of 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
Stone-free rate at 3 months of 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
次要结局
- 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.
- Post-operative pain will be assessed using a numerical pain scale ranging from 0 to 10 in the recovery room, in the service and at the discharge.
- Furosemide adverse events will be assessed.
- Effect of the prescription of an alpha-blocker will be looked at considering the primary outcome
- Evaluation of agreement between the imaging analysis of the urologist and the specialized radiologist will be looked at considering the primary outcome. Urologists will assess CT-Scan while the study is going on while specialized radiologists will assess the CT Scan at the end of the study.
研究者
LETOUCHE Marie-Lou
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (9)
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