Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Calculi
Intervention: Antioxidant group (Drug); Calcium Channel Blockers (Drug); Angiotensin receptor blocker group (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mansoura University Official(s) and/or principal investigator(s): Ahmed R. EL-Nahas, MD, Principal Investigator, Affiliation: Mansoura University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Renal damage
Secondary outcome: The mechanisms of renal protection
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Urology and Nephrology Center, Mansoura 35516, Egypt
Additional Information
Starting date: August 2012
Last updated: October 8, 2014
|