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

Primary Purpose

Acute Kidney Injury

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

vitamin E +Selenium

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

increased amount of urinary or serum NGAL after controlled hypotension

Secondary Outcome Measures

Full Information

NCT ID

NCT01554345

First Posted

February 19, 2012

Last Updated

March 13, 2012

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01554345

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

vitamin E +Selenium

Intervention Description

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

Primary Outcome Measure Information:

Title

increased amount of urinary or serum NGAL after controlled hypotension

Time Frame

from 2 hours to 24 hours after controlled hypotension

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoodreza Torkaman, resident

Phone

0098 917 105 0954

MRZTORKAMAN@yahoo.com

Facility Information:

Facility Name

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

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

Phone

0098 21 6119 2828

roaf2009@yahoo.com

First Name & Middle Initial & Last Name & Degree

Mahmoodreza Torkaman, Resident

12. IPD Sharing Statement

Learn more about this trial

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

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