A Randomized Controlled Trial for Evaluating Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Renal damage
研究概览
简要总结
This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.
详细描述
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Well functioning kidney (serum creatinine <1.2 mg/dl).
- •Solitary renal stone.
- •Size: 25 mm or less in the largest diameter.
排除标准
- •Contraindications to ESWL
- •Previous surgical treatment of renal stones.
- •Congenital renal anomalies.
- •Pediatric patients (age <18 years).
- •Patients with Diabetes or hypertension
研究组 & 干预措施
Control group
They will receive placebo
干预措施: Placebo (Drug)
Antioxidant group
They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
干预措施: Antioxidant group (Drug)
Calcium channel Blockers
They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
干预措施: Calcium Channel Blockers (Drug)
Angiotensin receptor blocker group
They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
干预措施: Angiotensin receptor blocker group (Drug)
结局指标
主要结局
Renal damage
时间窗: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.
次要结局
- The mechanisms of renal protection(Before ESWL, 2 hours and 1 week after ESWL)
研究者
Ahmed R. EL-Nahas
Assistant Professor of Urology
Mansoura University