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Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest

NCT02390999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-05-03

No results posted yet for this study

Summary

3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest patients. The investigators are challenged in our attempt to predict outcome of these patients by both low body temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma.

This study is a substudy in a large international multicenter randomized trial that investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays standard of 24 hours.

In this substudy the investigators will approach early prediction of neurological outcome using a combination of new examinations backed up by well established ones to engage this challenge from different angles and find a battery of combined examinations, that together will enable us to accurately predict outcome at an earlier stage.

Our examinations have been chosen from the three fields of neurophysiology, biochemistry and neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic reliability.

Conditions

  • Cardiac Arrest

Interventions

PROCEDURE

48 hours of therapeutic hypothermia

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • ThermoFisher Scientific Brahms Biomarkers France

    collaborator INDUSTRY

  • Regionshospitalet Hammel Neurocenter

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Denmark
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390999 on ClinicalTrials.gov