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

Phase 2

• Conditions: Acute Kidney Injury

• Registration Number: NCT01554345
• Lead Sponsor: 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

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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-02-19
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Study First Posted: 2012-03-14
• Last Update Posted: 2012-03-14
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
increased amount of urinary or serum NGAL after controlled hypotension	from 2 hours to 24 hours after controlled hypotension

Trial Locations

Locations (1)

Tehran university of medical sciences, Imam Khomeini Hospital, neurosurgery operation room and ward; 🇮🇷 Tehran, Iran, Islamic Republic of