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
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Kidney Calculi
- Sponsor
- Mansoura University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Renal damage
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ahmed R. EL-Nahas
Assistant Professor of Urology
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •Well functioning kidney (serum creatinine \<1.2 mg/dl).
- •Solitary renal stone.
- •Size: 25 mm or less in the largest diameter.
Exclusion Criteria
- •Contraindications to ESWL
- •Previous surgical treatment of renal stones.
- •Congenital renal anomalies.
- •Pediatric patients (age \<18 years).
- •Patients with Diabetes or hypertension
Arms & Interventions
Control group
They will receive placebo
Intervention: Placebo
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
Intervention: Antioxidant group
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
Intervention: Calcium Channel Blockers
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
Intervention: Angiotensin receptor blocker group
Outcomes
Primary Outcomes
Renal damage
Time Frame: 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.
Secondary Outcomes
- The mechanisms of renal protection(Before ESWL, 2 hours and 1 week after ESWL)