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

Phase 4

Completed

• Conditions: Kidney Calculi
• Interventions: Drug: Placebo; Drug: Antioxidant group; Drug: Calcium Channel Blockers; Drug: Angiotensin receptor blocker group

• Registration Number: NCT01675362
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Primary Completion: 2014-08
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Well functioning kidney (serum creatinine <1.2 mg/dl).
2. Solitary renal stone.
3. Size: 25 mm or less in the largest diameter.

Exclusion Criteria

1. Contraindications to ESWL
2. Previous surgical treatment of renal stones.
3. Congenital renal anomalies.
4. Pediatric patients (age <18 years).
5. Patients with Diabetes or hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	They will receive placebo
Antioxidant group	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
Calcium channel Blockers	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
Angiotensin receptor blocker group	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

Primary Outcome Measures

Name	Time	Method
Renal damage	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 Outcome Measures

Name	Time	Method
The mechanisms of renal protection	Before ESWL, 2 hours and 1 week after ESWL	The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt