A clinical study tofind out whether selenium (a trace element) improves brain function after cardiac arrest

Phase 1

• Conditions: Cardiac Arrest with successful resuscitation; MedDRA version: 14.0Level: PTClassification code 10007515Term: Cardiac arrestSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001074-26-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-09
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Cardiac arrest
Successful Resuscitation
Age >18

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Polytrauma
Pregnancy
Any condition that makes it likely that the patient will not survive 24 hours

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: Administration of high dose selenium for 7 days after cardiac arrest is associated with a significant reduction of neuron specific enolase;Secondary Objective: Secondary objective: Administration of high dose selenium for 7 days after cardiac arrest is associated with a significant reduction of c-reactive protein, procalcitonin, interleukin 6, peroxide, peroxidase, OLAB, MDA-LDL IG, TAC, ADMA, selenium and gluthathion peroxidise levels. <br>Administration of high dose selenium for 7 days after cardiac arrest is associated with an improvement of neurological performance measured by the Glasgow-Pittsburgh performance score;Primary end point(s): Administration of high dose selenium for 7 days after cardiac arrest is associated with a significant reduction of neuron specific enolase;Timepoint(s) of evaluation of this end point: Day 0, day 1, day 3, day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Administration of high dose selenium for 7 days after cardiac arrest is associated with a significant reduction of c-reactive protein, procalcitonin, interleukin 6, peroxide, peroxidase, OLAB, MDA-LDL IG, TAC, ADMA, selenium and glutathione peroxidase levels. <br>Administration of high dose selenium for 7 days after cardiac arrest is associated with an improvement of neurological performance measured by the Glasgow-Pittsburgh performance score and the NIH Stroke Scale<br>;Timepoint(s) of evaluation of this end point: Day 0, day 1, day 3, day 7, day 90 and day 180 (clinical scores)