Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients

Study Overview
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Brief Summary
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Some patients with refractory cardiac arrest can be saved by ECMO-treatment. However predictors defining which patients can be saved, and not, is missing. This shall be evaluated together with neurological prognostic factors during ECMO treatment. Long term cognitive function will be evaluated by physical examination and standardized tests in survivors. Costs will be assessed. Infection rates in patients will be studied.

Detailed Description
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75-80% of patients with cardiac arrest don't survive. Some of those, who despite advanced cardiopulmonary resuscitation don't get their circulation back, can be saved by ECMO-treatment. This is called E-CPR. In E-CPR the selection of patients is of uttermost importance. Despite this good selection criteria are missing. ECMO-treatment it self is also associated with severe morbidity and high mortality, where long term evaluation of cognitive function is missing. In ECPR patients, pre arrest factors as well as measurable circulatory and other prognostic factors are measured during ECPR. Circulatory effect of CPR is measured by end tidal carbon dioxide, NIRS-brain, pupil diameter, spontaneous movement, spontaneous breathing, serum lactate and pH during CPR. All ECMO-treated patients at Sahlgrenska University hospital since 2010 are included. Since 2016 all ECPR patients has been prospectively followed and the above mentioned circulatory factors have been evaluated during CPR in order to find predictors of good neurological outcome of ECPR. Neurological prognostication according to European Guidelines of post cardiac arrest care is done, including early CT-scan of the brain, S-NSE, S100B, EEG, assessment of myoclonic status and pupil and corneal reflexes. The general CPR guidelines accuracy for survival with good neurological outcome in ECPR patients is tested. Both ECPR and ECMO-patients without previous CPR will have a long term follow up with standardized questionnaires (CPC, MRS, Mocca, Trailmaking test, MQ-5D, SF36, etc) and physiological and motor tests. Qualy will be calculated. The cost of the treatment in hospital will be assessed. The infection rate in all ECMO-patients from 2004- will be evaluated by blood and airway Cultures.

Official Title
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Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients

Conditions
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Cardiac Arrest, Extracorporeal Membrane Oxygenation, Hypoxia-Ischemia, Brain

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECMO-treated patients att Sahlgrenska University Hospital Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECPR patients<br>Patients that is put om ECMO during cardiac arrest | Other: No intervention<br>* No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest<br>|
| ECMO patients, non-ECPR<br>Patients that is put on ECMO due to circulatory failure but not cardiac arrest | Other: No intervention<br>* No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with Cerebral Performance Category 1 or 2. | Good neurological outcome in ECPR-patients | 1 year | 
| Physicians Global Assessment to measure quality of life | Quality of Life in survivors after ECPR and ECMO without cardiac arrest, Measured with in depth interviews | 1-15 years | 
| Positive blood Cultures | Infection rates in ECMO-patients | 1 month | 
| Euro Qualy - 5 dimension (EQ-5D) | Assesment of quality of life | 1-7 years | 
| Cerebral Performance Scale (CPC) | Assessment of cerebral performance. 1-5, where 1-2 is considered good outcome | 1-7 years | 
| Modified Rankin scale (MRs) | Assessmenty of cognitive function. 0-6, where 0 is best. | 1-7 years | 
| Trailmaking test | Assessmenty of cognitive function. Shorter time is better. | 1-7 years | 
| Short Form -36 (SF-36) | Quality of life. 8 scaled scores from 0-100, where 100 is best. | 1-7 years | 
| New York heart association class (NYHA class) | Assessment of physical function.1-4, where 1 is best | 1-7 years |