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

Kidney Calculi Clinical Trial

— SWL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675362
• Other study ID #: 4228
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2012
• Last updated: October 8, 2014
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Science and Technological Development Fund
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi

Intervention

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
• 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
They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
• Placebo
They will receive placebo

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	Yes