Effect of Vitamin E+Selenium on Kidney Function in Controlled Hypotension
Assessment of Preventive Effect of Vitamin E +Selenium on Acute Kidney Injury Through NGAL in Patients Undergoing Controlled Hypotension During Neurosurgery Operations
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedMarch 14, 2012
March 1, 2012
1.2 years
February 19, 2012
March 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
increased amount of urinary or serum NGAL after controlled hypotension
from 2 hours to 24 hours after controlled hypotension
Interventions
vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation
Eligibility Criteria
You may qualify if:
- All patients who are candidate for brain surgery under controlled hypotension
You may not qualify if:
- Positive history of renal disease
- Positive history of diabetes mellitus, CHF, HTN, Breast cancer, fever, leukocytosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tehran university of medical sciences, Imam Khomeini Hospital, neurosurgery operation room and ward
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 19, 2012
First Posted
March 14, 2012
Study Start
June 1, 2011
Primary Completion
August 1, 2012
Last Updated
March 14, 2012
Record last verified: 2012-03