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
|Condition or disease|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
- 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
- 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)
- 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 ]
- 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 ]
- Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation [ Time Frame: up to 72 hours after CPR ]
- Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation [ Time Frame: up to 72 hours after CPR ]
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
|Department of Intensive Care Medicine University Hospital Bern (Inselspital)|
|Bern, Switzerland, 3010|
|Study Chair:||Jukka Takala, MD, PhD||Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)|