Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest

NCT ID: NCT02722460

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-06-30

Brief Summary

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The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

Detailed Description

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The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

This will be a prospective mono-center survey (Department of Intensive Care Medicine, University Hospital Bern), evaluating the survival and neurological outcome after cardiac arrest. The study will be performed in cooperation with the Department of Neurology and Neuroradiology, University Hospital Bern.

Inclusion: all patients surviving resuscitation after cardiac arrest older than 18 years. Detailed medical and neurological examination including 6-lead continuous EEG, 10/20 EEG and somatosensory evoked potentials, standard blood tests including Neuron-specific Enolase (NSE) and cerebral MRI will be assessed during the first 72 hours after cardiac arrest. Structured telephone interviews to determine outcome parameters (Cerebral Performance Category CPC, modified Ranking Scale mRS) will take place at day 30, after 3 and 12 month.

The results of the registry could identify early comatose patients after cardiac arrest with no chance of a good neurological recovery and regain consciousness to avoid unjustified expectations of relatives and prolonged life-sustaining therapies. A good neurological recovery is defined as a CPC of 1 and 2 or a mRS 0-2. An unfavourable neurological outcome will be defined as persistent vegetative state and death (CPC 4 and 5, mRS 5-6).

Conditions

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Cardiac Arrest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age at least 18 years
* Down time ≤ 20 minutes (down time = time breakdown to start of professional resuscitation)
* Persistent stable circulation without further need of CPR
* Glasgow Coma Scale \< 8 after return of spontaneous circulation

Exclusion Criteria

* Cardiac arrest due to neurological causes (stroke, intracerebral hemorrhage, subarachnoid hemorrhage, SUDEP - sudden unexpected death in epilepsy)
* Cardiac arrest due to unobserved asystole
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matthias Haenggi

OTHER

Sponsor Role lead

Responsible Party

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Matthias Haenggi

Attending Physician, Departement of Intensive Care Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jukka Takala, MD, PhD

Role: STUDY_CHAIR

Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Locations

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Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Kagi E, Weck A, Iten M, Levis A, Haenggi M. Value of the TTM risk score for early prognostication of comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital. Swiss Med Wkly. 2020 Sep 9;150:w20344. doi: 10.4414/smw.2020.20344. eCollection 2020 Sep 7.

Reference Type DERIVED
PMID: 32920792 (View on PubMed)

Other Identifiers

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KEK BE 116/15

Identifier Type: -

Identifier Source: org_study_id

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