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

October 8, 2014 updated by: Ahmed R. EL-Nahas, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
They will receive placebo
Drug: Placebo
They will receive 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 Names:
  • 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 Names:
  • 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 Names:
  • Losartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before ESWL, 2 hours and 1 week after ESWL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R. EL-Nahas, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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