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

NCT ID: NCT01554345

Last Updated: 2012-03-14

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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vitamin E +Selenium

vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahed Hosein Khan

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tehran university of medical sciences, Imam Khomeini Hospital, neurosurgery operation room and ward

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mahmoodreza Torkaman, resident

Role: CONTACT

0098 917 105 0954

Facility Contacts

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Role: primary

0098 21 6119 2828

Other Identifiers

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89-04-30-11624

Identifier Type: -

Identifier Source: org_study_id

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