Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Calculi

Intervention / Treatment
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* Drug: Antioxidant group
* Drug: Calcium Channel Blockers
* Drug: Angiotensin receptor blocker group
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>They will receive placebo | Drug: Placebo<br>* They will receive placebo<br>|
| Active Comparator: Antioxidant group<br>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 | Drug: Antioxidant group<br>* 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<br>* Other names: Selenium ACE;|
| Active Comparator: Calcium channel Blockers<br>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 | Drug: Calcium Channel Blockers<br>* 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<br>* Other names: Verapamil;|
| Active Comparator: Angiotensin receptor blocker group<br>They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week | Drug: Angiotensin receptor blocker group<br>* They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week<br>* Other names: Losartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal damage | The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. | two hours and one week after Extracorporeal shock wave lithotripsy (ESWL) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mechanisms of renal protection | The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI | Before ESWL, 2 hours and 1 week after ESWL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers