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Completed

NCT Number: NCT02722460

Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Bern, 3010, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. incidence of survival

    Time frame: 30 days after CPR

    incidence of patients still alive 30 days after cardiac arrest or patients discharged alive from hospital

Secondary outcomes

  1. incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale

    Time frame: 72 hours after CPR

    incidence of death within the first 72 hours after cardiac arrest and of death or unfavorable outcome according to the Cerebral Performance Categories Scales 4 and 5 (CPC 4 - Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness, CPC 5 - Brain death)

  2. Number of Patient with a low voltage EEG, defined as amplitude below 20 microvolt more than 24 to 72 hours after resuscitation.

    Time frame: up to 72 hours after CPR

  3. Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation

    Time frame: 72 hours after CPR

  4. Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation

    Time frame: up to 72 hours after CPR

  5. Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation

    Time frame: up to 72 hours after CPR

Sponsors and collaborators

Lead sponsor

Matthias Haenggi

Other

Registry information

Official study title

Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest

Acronym: CPR

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Mar 30, 2016
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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