Clinical trial NCT02722460: Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest
Official title: Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: incidence of survival
timeFrame: 30 days after CPR
Secondary outcomes:
measure: incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale
timeFrame: 72 hours after CPR
measure: Number of Patient with a low voltage EEG, defined as amplitude below 20 microvolt more than 24 to 72 hours after resuscitation.
timeFrame: up to 72 hours after CPR
measure: Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation
timeFrame: 72 hours after CPR
measure: Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation
timeFrame: up to 72 hours after CPR
measure: Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation
timeFrame: up to 72 hours after CPR
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care Medicine University Hospital Bern (Inselspital)
Study officials:
affiliation: Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)
name: Jukka Takala, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.