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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675362

Acronym

SWL

Enrollment

160

Registered

2012-08-29

Start date

2012-08-31

Completion date

2014-10-31

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi

Keywords

Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers

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.

Interventions

DRUGAntioxidant 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

DRUGCalcium 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

DRUGAngiotensin 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

DRUGPlacebo

They will receive placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026