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Clinical Trials/NCT02722460
NCT02722460
Completed
Not Applicable

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

Matthias Haenggi1 site in 1 country200 target enrollmentJanuary 2016
ConditionsCardiac Arrest

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Matthias Haenggi
Enrollment
200
Locations
1
Primary Endpoint
incidence of survival
Status
Completed
Last Updated
3 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
June 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Matthias Haenggi
Responsible Party
Sponsor Investigator
Principal Investigator

Matthias Haenggi

Attending Physician, Departement of Intensive Care Medicine

Insel Gruppe AG, University Hospital Bern

Eligibility 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

Outcomes

Primary Outcomes

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

  • incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale(72 hours after CPR)
  • Number of Patient with a low voltage EEG, defined as amplitude below 20 microvolt more than 24 to 72 hours after resuscitation.(up to 72 hours after CPR)
  • Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation(72 hours after CPR)
  • Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation(up to 72 hours after CPR)
  • Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation(up to 72 hours after CPR)

Study Sites (1)

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