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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01675362

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi	Drug: Antioxidant group Drug: Calcium Channel Blockers Drug: Angiotensin receptor blocker group Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group They will receive placebo	Drug: Placebo They will receive placebo
Active Comparator: 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	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 Other Names: Selenium ACE
Active Comparator: 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	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 Other Names: Verapamil
Active Comparator: 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	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 Other Names: Losartan

Outcome Measures

Primary Outcome Measures

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

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