NCT02390999

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

March 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

March 2, 2015

Last Update Submit

May 1, 2017

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Glasgow-Pittsburgh Cerebral Performance Categories (CPC) after 6 months

    To evaluate neurologic recovery using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC) 6 months after cardiac arrest. The CPC-score will be dichotomized in good (CPC 1-2) and poor (CPC 3-5) outcome.

    6 months

Secondary Outcomes (1)

  • Area under the curve

    72 hours

Other Outcomes (1)

  • Presence of brainstem reflexes

    72 hours

Study Arms (2)

24 hours of therapeutic hypothermia

NO INTERVENTION

24 hours of therapeutic hypothermia to a target temperature of 32-34 degrees in comatose cardiac arrest patients is standard treatment in Denmark.

48 hours of therapeutic hypothermia

EXPERIMENTAL

48 hours of therapeutic hypothermia to a target temperature of 32-34 degrees

Procedure: 48 hours of therapeutic hypothermia

Interventions

48 hours of therapeutic hypothermiaPROCEDURE
48 hours of therapeutic hypothermia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out-of-hospital cardiac arrest with presumable cardiac origin
  • Restored spontaneous circulation after resuscitation (No need for cardiac compressions during 20 min, and clinical sign of circulation)
  • Glasgow Coma Score (GCS) \< 8
  • Age \>= 18, \< 80 years

You may not qualify if:

  • Estimated time interval from collapse to return of spontaneous circulation\>60 min
  • Cardiac arrest with presumable non-cardiac origin (hypoxia etc.).
  • In hospital cardiac arrest
  • Terminal disease
  • Unwitnessed asystolia
  • Time from cardiac arrest to initiation of cooling\>240 min.
  • Pregnancy
  • Persistent cardiogenic shock, systolic blood pressure\<80 mmHg despite vasoactive treatment
  • Cerebral performance category (CPC) 3-4 before cardiac arrest.
  • Suspicious or confirmed intracerebral bleeding
  • Suspicious or confirmed acute stroke
  • Acute CABG
  • No informed consent from relatives
  • No informed consent from general practitioner
  • Patient unstable
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Stavanger University Hospital

Stavanger, Norway

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 18, 2015

Study Start

March 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

May 3, 2017

Record last verified: 2015-02

Locations

DK(1)NO(1)