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

Acute Kidney Injury Clinical Trial

Official title:

Assessment of Preventive Effect of Vitamin E +Selenium on Acute Kidney Injury Through NGAL in Patients Undergoing Controlled Hypotension During Neurosurgery Operations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01554345
• Other study ID #: 89-04-30-11624
• Status: Recruiting
• Phase: Phase 2
• First received: February 19, 2012
• Last updated: March 13, 2012
• Start date: June 2011

Study information

• Verified date: March 2012
• Source: Tehran University of Medical Sciences
• Contact: Mahmoodreza Torkaman, resident
• Phone: 0098 917 105 0954
• Email: MRZTORKAMAN[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran university of medical sciences, Imam Khomeini Hospital, neurosurgery operation room and ward	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increased amount of urinary or serum NGAL after controlled hypotension		from 2 hours to 24 hours after controlled hypotension	Yes