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

NCT ID: NCT01675362

Last Updated: 2014-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Kidney Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

They will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

They will receive placebo

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

Group Type ACTIVE_COMPARATOR

Antioxidant group

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Calcium Channel Blockers

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Angiotensin receptor blocker group

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Placebo

They will receive placebo

Intervention Type DRUG

Other Intervention Names

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Selenium ACE Verapamil Losartan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed R. EL-Nahas

Assistant Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed R. EL-Nahas, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Urology and Nephrology Center

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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4228

Identifier Type: -

Identifier Source: org_study_id

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