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

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Kidney Calculi

Treatments: Drug: Placebo; Drug: Angiotensin receptor blocker group; Drug: Calcium Channel Blockers; Drug: Antioxidant group

Study type: Interventional

Funder types: Other

Identifiers

NCT01675362

4228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

They will receive placebo

Treatment:

Drug: Placebo

Antioxidant group

Active Comparator group

Description:

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

Treatment:

Drug: Antioxidant group

Calcium channel Blockers

Active Comparator group

Description:

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

Treatment:

Drug: Calcium Channel Blockers

Angiotensin receptor blocker group

Active Comparator group

Description:

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

Treatment:

Drug: Angiotensin receptor blocker group