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

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Antioxidant group
Calcium Channel Blockers
Angiotensin receptor blocker group
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Calculi focused on measuring Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Antioxidant group

Calcium channel Blockers

Angiotensin receptor blocker group

Arm Description

They will receive placebo

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

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

They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week

Outcomes

Primary Outcome Measures

Renal damage
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
The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI

Full Information

First Posted
August 27, 2012
Last Updated
October 8, 2014
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01675362
Brief Title
Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
Acronym
SWL
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
They will receive placebo
Arm Title
Antioxidant group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Calcium channel Blockers
Arm Type
Active Comparator
Arm Description
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
Arm Title
Angiotensin receptor blocker group
Arm Type
Active Comparator
Arm Description
They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
Intervention Type
Drug
Intervention Name(s)
Antioxidant group
Other Intervention Name(s)
Selenium ACE
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Calcium Channel Blockers
Other Intervention Name(s)
Verapamil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Angiotensin receptor blocker group
Other Intervention Name(s)
Losartan
Intervention Description
They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
They will receive placebo
Primary Outcome Measure Information:
Title
Renal damage
Description
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.
Time Frame
two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
Secondary Outcome Measure Information:
Title
The mechanisms of renal protection
Description
The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI
Time Frame
Before ESWL, 2 hours and 1 week after ESWL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed R. EL-Nahas, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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