Effect of Furosemide on Outcome of Extracorporeal Shock Wave Lithotripsy for Renal and Ureteral Calculi; a Randomized, Triple-blinded, Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Stone-free rate
研究概览
简要总结
The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients.
The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
详细描述
The present study takes the form of a double-blind, randomized clinical trial. The study conforms to the principles stated in the Declaration of Helsinki. Written informed consent is obtained from all subjects prior to enrolment. All participants are made aware of the study protocol and can withdraw from the study at any point. Given that furosemide does not adversely affect patients who do not have cardiovascular or renal diseases, no complications are predicted. The trial is pending registration with clinicaltrials.gov. This protocol was conceived following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
By taking into account an alpha error of 0.05 and a test power of 80%, the number of subjects in each group was calculated at 232. Considering a dropout rate of 10%, 250 subjects are to be included in each group.
Using block randomization, the patients are randomly assigned to one of two groups by a statistician outside of the research group. The codes for each group remain unknown to the researchers until after statistical analysis, with only the nurse and physician in charge of delivering the therapy and monitoring the patients being made aware.
All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL, which is to be performed in the standard manner. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Given that furosemide may theoretically cause pain secondary to hydronephrosis, pain will be checked for all participants via a telephone interview 24 hours later using a visual analog scale (VAS) of 0 to 10.
The outcomes and possible side effects of ESWL are evaluated for all patients after two and twelve weeks. A KUB X-ray is used for follow-up in patients with radiopaque stones, while a KUB CT scan is used otherwise. The primary outcome measure is the stone-free rate after two and twelve weeks, considered as the absence of a stone ≥ 4 mm. Secondary outcome measures include pain after 24 hours, need for re-ESWL, and need for surgery.
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
- Double (Participant, Investigator)
盲法说明
Using block randomization, the patients are randomly assigned to one of two groups by a statistician outside of the research group. The codes for each group remain unknown to the researchers until after statistical analysis, with only the nurse and physician in charge of delivering the therapy and monitoring the patients being made aware.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years
- •Patients with renal or ureteral calculi referred by attending urologists to the ESWL Clinic of Shahid Faghihi Hospital, affiliated to Shiraz University of Medical Sciences (Shiraz, Iran)
排除标准
- •An anatomic anomaly in urinary system
- •Coagulopathy
- •Untreated urinary tract infection
- •Prior urologic surgery
- •Simultaneous unilateral renal and ureteral stones
- •Kidney failure (serum creatinine > 1.8 mg/dl)
- •Cardiovascular disease
- •Hypertension
- •Morbid obesity (BMI > 40 kg/m2)
- •History of allergy to furosemide, glibenclamide, hydrochlorothiazide, or acetazolamide.
- •Pregnancy
- •Single kidney
研究组 & 干预措施
Intervention Group
40 mg of furosemide IV + IV midazolam + 1000 ml of normal saline 30 minutes before ESWL
- Standard ESWL
干预措施: Furosemide 40 mg (Drug)
Intervention Group
40 mg of furosemide IV + IV midazolam + 1000 ml of normal saline 30 minutes before ESWL
- Standard ESWL
干预措施: Conventional Treatment (Other)
Control Group
IV midazolam + 1000 ml of normal saline 30 minutes before ESWL
- Standard ESWL
干预措施: Conventional Treatment (Other)
结局指标
主要结局
Stone-free rate
时间窗: 3 months after intervention
The absence of a stone ≥ 4 mm
次要结局
- Renal colic on VAS of 0-10(24 hours after intervention)
- Number of participants with need for re-ESWL(Within 3 months after intervention)
- Number of participants with need for surgery(Within 3 months after intervention)
研究者
Seyed Hossein Hosseini
Principal Investigator
Shiraz University of Medical Sciences