Selenium to Improve Neurological Outcome After Cardiac Arrest (SCPR)
Primary Purpose
Cardiac Arrest
Status
Withdrawn
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Sodium-selenite
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest focused on measuring cardiac arrest, resuscitation, neurological outcome
Eligibility Criteria
Inclusion Criteria:
- Cardiac arrest
- Successful Resuscitation
- Age >18
Exclusion Criteria:
- Polytrauma
- Pregnancy
- Any condition that makes it likely that the patient will not survive 24 hours
Sites / Locations
- Department of Internal Medicine, Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sodium-selenite infusion
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
neuron specific enolase
Reduction of neuron specific enolase below by more than 4.4 µg/l at 72 hours after admission to the hospital
Secondary Outcome Measures
inflammation
Reduction of C-reactive protein, procalcitonin, interleukin 6
oxidative stress markers
Reduction in peroxide, peroxidase, OLAB, MDA-LDL IG, TAC, ADMA, selenium and glutathione peroxidase levels
neurological function
Improvement of NIH stroke scale and Glasgow Pittsburgh Performance score
Selenium blood levels
Increase in selenium levels in whole blood
glutathion peroxidase plasma levels
Improvement in glutathion peroxidase plasma levels
Full Information
NCT ID
NCT01390506
First Posted
July 4, 2011
Last Updated
December 12, 2017
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT01390506
Brief Title
Selenium to Improve Neurological Outcome After Cardiac Arrest
Acronym
SCPR
Official Title
Effect of High Dose Selenium on Inflammation and Neurological Outcome After Cardiac Arrest: A Randomized, Double Blind Placebo Controlled Phase 2a Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The company did not provide the study product
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
When cardiopulmonary resuscitation results in the return of spontaneous circulation, intensive care is required to optimize neurological recovery. The pathophysiological reactions that follow hypoxic brain injury are complex, and the mechanisms by which ischemia causes neuronal death leading to postanoxic encephalopathy are only partly understood to date. Therapeutic hypothermia improves brain function after cardiopulmonary resuscitation. Injury however can be ongoing even after the return of spontaneous circulation, giving the clinician an additional window of opportunity to treat and protect the injured brain [5]. Therefore there is an unmet clinical need for further therapeutic strategies. Strategies to counteract the deleterious effects of oxygen-derived free radicals after cerebral reperfusion have been studied for long.
The trace element selenium is part of the enzyme glutathione peroxidase which belongs to the endogenous defence mechanisms against oxidative stress. Clinical data suggest that supplementation of selenium may be beneficial in critically ill patients and in neurodegenerative diseases including, among others, Parkinson's disease, stroke, and epilepsy, where oxidative stress plays an important pathophysiological role. In SIRS, sepsis and septic shock doses up to 4000µg per day have been proven to be safe A recent retrospective analysis supported the hypothesis that early administration of selenium may improve neurological outcome after cardiac arrest.
Therefore the purpose of this study is to explore the influence of early administration of selenium on neurological outcome after cardiopulmonary resuscitation by a randomized, placebo-controlled, single-center study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, resuscitation, neurological outcome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium-selenite infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Sodium-selenite
Other Intervention Name(s)
selenase
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0,9% sodium chloride
Intervention Description
0,9% sodium chloride is administered intravenously
Primary Outcome Measure Information:
Title
neuron specific enolase
Description
Reduction of neuron specific enolase below by more than 4.4 µg/l at 72 hours after admission to the hospital
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
inflammation
Description
Reduction of C-reactive protein, procalcitonin, interleukin 6
Time Frame
7 days
Title
oxidative stress markers
Description
Reduction in peroxide, peroxidase, OLAB, MDA-LDL IG, TAC, ADMA, selenium and glutathione peroxidase levels
Time Frame
7 days
Title
neurological function
Description
Improvement of NIH stroke scale and Glasgow Pittsburgh Performance score
Time Frame
6 months
Title
Selenium blood levels
Description
Increase in selenium levels in whole blood
Time Frame
7 days
Title
glutathion peroxidase plasma levels
Description
Improvement in glutathion peroxidase plasma levels
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiac arrest
Successful Resuscitation
Age >18
Exclusion Criteria:
Polytrauma
Pregnancy
Any condition that makes it likely that the patient will not survive 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Stadlbauer, MD
Organizational Affiliation
Department of Internal Medicine, Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
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Selenium to Improve Neurological Outcome After Cardiac Arrest
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