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Completed

NCT Number: NCT01675362

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

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Antioxidant group

Drug

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

Calcium Channel Blockers

Drug

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

Angiotensin receptor blocker group

Drug

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

Placebo

Drug

They will receive placebo

Primary outcomes

  1. Renal damage

    Time frame: 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 outcomes

  1. The mechanisms of renal protection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Acronym: SWL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2012
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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