Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554345
Recruitment Status : Unknown
Verified March 2012 by Zahed Hosein Khan, Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):
Zahed Hosein Khan, Tehran University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Kidney Injury Drug: vitamin E +Selenium Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Estimated Primary Completion Date : August 2012

Intervention Details:
  • Drug: vitamin E +Selenium
    vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation

Primary Outcome Measures :
  1. increased amount of urinary or serum NGAL after controlled hypotension [ Time Frame: from 2 hours to 24 hours after controlled hypotension ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554345

Layout table for location contacts
Contact: Mahmoodreza Torkaman, resident 0098 917 105 0954

Layout table for location information
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   
Principal Investigator: Mahmoodreza Torkaman, Resident         
Sponsors and Collaborators
Tehran University of Medical Sciences

Layout table for additonal information
Responsible Party: Zahed Hosein Khan, professor, Tehran University of Medical Sciences Identifier: NCT01554345    
Other Study ID Numbers: 89-04-30-11624
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements