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Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest (CPR)

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ClinicalTrials.gov Identifier: NCT02722460
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Matthias Haenggi, University Hospital Inselspital, Berne

Brief Summary:
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.

Condition or disease
Cardiac Arrest

Detailed Description:

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).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with in or out of hospital cardiac arrest and a Glasgow Coma Scale below 8 after emergency service arrived who fulfill the inclusion criteria and none of the exclusion criteria will be included in the prospective registry.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722460


Locations
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Switzerland
Department of Intensive Care Medicine University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Sponsors and Collaborators
Matthias Haenggi
Investigators
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Study Chair: Jukka Takala, MD, PhD Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Additional Information:

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Responsible Party: Matthias Haenggi, Attending Physician, Departement of Intensive Care Medicine, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02722460     History of Changes
Other Study ID Numbers: KEK BE 116/15
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases