Study Stopped
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Selenium to Improve Neurological Outcome After Cardiac Arrest
SCPR
Effect of High Dose Selenium on Inflammation and Neurological Outcome After Cardiac Arrest: A Randomized, Double Blind Placebo Controlled Phase 2a Study
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
After cardiac arrest and successful resuscitation it can happen that the brain function of a patient is impaired because the brain was without oxygen for a prolonged period of time. Several strategies have been studied to improve brain function after cardiac arrest. Cooling of the patients is routinely used today. The trace element selenium has several biological functions and is important for defense mechanisms against oxidative stress, which occurs after cardiac arrest and successful resuscitation. critically ill patients have low selenium blood levels. Therefore the investigators hypothesize that giving selenium after cardiac arrest and successful resuscitation might improve brain function.
Trial Health
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Started Jan 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 13, 2017
December 1, 2017
1.5 years
July 4, 2011
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neuron specific enolase
Reduction of neuron specific enolase below by more than 4.4 µg/l at 72 hours after admission to the hospital
72 hours
Secondary Outcomes (5)
inflammation
7 days
oxidative stress markers
7 days
neurological function
6 months
Selenium blood levels
7 days
glutathion peroxidase plasma levels
7 days
Study Arms (2)
Sodium-selenite infusion
ACTIVE COMPARATORDi-sodium-selenite-pentahydrate (Na 2SeO3.5H2O) in 0,9% sodium chloride is administered intravenously at a does of 3000µg on day 0, 2000µg on day 1 and 2 and at a dose of 1000µg per day on day 3-6.
Placebo
PLACEBO COMPARATOR0.9% sodium chloride
Interventions
Di-sodium-selenite-pentahydrate (Na 2SeO3.5H2O) in 0,9% sodium chloride is administered intravenously at a does of 3000µg on day 0, 2000µg on day 1 and 2 and at a dose of 1000µg per day on day 3-6.
0,9% sodium chloride is administered intravenously
Eligibility Criteria
You may qualify if:
- Cardiac arrest
- Successful Resuscitation
- Age \>18
You may not qualify if:
- Polytrauma
- Pregnancy
- Any condition that makes it likely that the patient will not survive 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Medical University of Graz
Graz, 8010, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Stadlbauer, MD
Department of Internal Medicine, Medical University of Graz
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
- SPONSOR
Study Record Dates
First Submitted
July 4, 2011
First Posted
July 11, 2011
Study Start
January 1, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2019
Last Updated
December 13, 2017
Record last verified: 2017-12