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Effect of Vitamin E+Selenium on Kidney Function in Controlled Hypotension

This study is currently recruiting participants.
Verified March 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Zahed Hosein Khan, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01554345
First received: February 19, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether Kidney injury happens in controlled hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin ELISA Kit and if so, does VitaminE+Selenium prevent it


Condition Intervention Phase
Acute Kidney Injury
 Drug: vitamin E +Selenium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of Preventive Effect of Vitamin E +Selenium on Acute Kidney Injury Through NGAL in Patients Undergoing Controlled Hypotension During Neurosurgery Operations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • increased amount of urinary or serum NGAL after controlled hypotension [ Time Frame: from 2 hours to 24 hours after controlled hypotension ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: vitamin E +Selenium
    vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation
Detailed Description:

NGAL(Neutrophil Gelatinase Associated Lipocalin) is a 25KD protein which bounds with Gelatinase in Neutrophil granules.It is also expressed in epithelial cells of kidney tubules.NGAL increases in ischemic and toxic injuries of kidney. During controlled hypotension in brain operations injury to the kidneys might occur . This study is designed to assess this possibility and evaluate the effect of VitaminE+Selenium on prevention of this problem

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients who are candidate for brain surgery under controlled hypotension

Exclusion Criteria:

  • Positive history of renal disease
  • Positive history of diabetes mellitus, CHF, HTN, Breast cancer, fever, leukocytosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554345

Contacts
Contact: Mahmoodreza Torkaman, resident 0098 917 105 0954 MRZTORKAMAN@yahoo.com

Locations
Iran, Islamic Republic of
Tehran university of medical sciences, Imam Khomeini Hospital, neurosurgery operation room and ward Recruiting
Tehran, Iran, Islamic Republic of
Contact     0098 21 6119 2828     roaf2009@yahoo.com    
Principal Investigator: Mahmoodreza Torkaman, Resident            
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Zahed Hosein Khan, professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01554345     History of Changes
Other Study ID Numbers: 89-04-30-11624
Study First Received: February 19, 2012
Last Updated: March 13, 2012
Health Authority: Iran: Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Acute Kidney Injury
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013