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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University
ClinicalTrials.gov Identifier:
NCT01675362
First received: August 27, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Kidney Calculi
Drug: Antioxidant group
Drug: Calcium Channel Blockers
Drug: Angiotensin receptor blocker group
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Renal damage [ Time Frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Before ESWL, 2 hours and 1 week after ESWL ] [ Designated as safety issue: Yes ]
    The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI


Enrollment: 160
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
They will receive placebo
Drug: Placebo
They will receive placebo
Other Name: 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 Name: 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 Name: 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 Name: Losartan

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675362

Locations
Egypt
Urology and Nephrology Center
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ahmed R. EL-Nahas, MD Mansoura University
  More Information

No publications provided

Responsible Party: Ahmed R. EL-Nahas, Assistant Professor of Urology, Mansoura University
ClinicalTrials.gov Identifier: NCT01675362     History of Changes
Other Study ID Numbers: 4228
Study First Received: August 27, 2012
Last Updated: October 8, 2014
Health Authority: Egypt: Science and Technological Development Fund

Keywords provided by Mansoura University:
Extracorporeal shockwave lithotripsy (ESWL)
Kidney calculi
Renal protection
Antioxidants
Calcium channel blockers
Angiotensin receptor blockers

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Verapamil
Losartan
Calcium Channel Blockers
Antioxidants
Selenium
Angiotensin Receptor Antagonists
Calcium, Dietary
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Bone Density Conservation Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 19, 2014