Evaluation of eCPR Survivors
Study Details
Study Description
Brief Summary
A cardiac arrest event has severe impact on the patient´s health-related quality of life. Survival of cardiac arrest does not innately translate to favorable quality of life. In particular, highly invasive resuscitation strategies, including extracorporeal cardio-pulmonary resuscitation (ECPR) due to therapy-refractory cardiac arrest, may have impact on long-term outcomes. Therefore, apart from acute medical treatment and physical rehabilitation, long-term effects on cardio-pulmonary, physical and neuro-psychiatric functions after cardiac arrest survival have to be evaluated and optimized. We plan to investigate a bundle of cardio-pulmonary, physical and neuro-psychiatric functions in patients who survived a therapy-refratory cardiac arrest with ECPR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ECPR survivor Adult patient who survived therapy-refractory cardiac arrest with extracorporeal cardiopulmonary resuscitation (ECPR). |
Device: VA-ECMO or ECMELLA
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO); ECMELLA: VA-ECMO and left-ventricular Impella micro-axial pump
|
Outcome Measures
Primary Outcome Measures
- Left ventricular ejection fraction (LVEF) [LVEF witihin one year after index cardiac arrest event.]
LVEF measured with transthoracic echocardiography.
Secondary Outcome Measures
- Cognitive function [Cognitive function witihin one year after index cardiac arrest event.]
Cognitive function measured with a standardized questionnaire and following established scores: Mini-mental-status-test [0-30 points; higher score means better outcome], Cerebral Performance Categories Scale [1-5; lower score means better outcome].
- Sign and symptoms of heart failure [Sign and symptoms of heart failure witihin one year after index cardiac arrest event.]
Sign and symptoms of heart failure measured with a standardized questionnaire and following established score: European Quality of Life 5 Dimensions 3 Level Version [0-100 points; higher score means better outcome].
- Activity of daily living (ADL) [ADL witihin one year after index cardiac arrest event.]
ADL measured with a standardized questionnaire and following estbalished score: Barthel index [0-100 points; higher score means better outcome].
- Comorbidity level [Comorbidity level witihin one year after index cardiac arrest event.]
Comorbidity level measured with following established score: Charlson comorbidity index [0-24 points; lower score means better outcome].
- Number of cardiovascular medications [Number of cardiovascular medication witihin one year after index cardiac arrest event.]
Number of cardiovascular medications documented with a standardized questionnaire.
- Cardiac stress test: Ergometry [Physical function witihin one year after index cardiac arrest event.]
Quantitative test to evaluate cardiopulmonary exercise tolerance and physical capacity by using a bicycle.
- Cardiac stress test: Walking distance [Physical function witihin one year after index cardiac arrest event.]
Quantitative test to evaluate endurance and aerobic capacity by walking for six minutes (six minute walk test).
- Vital function: Blood pressure [Blood pressure witihin one year after index cardiac arrest event.]
Non-invasive blood pressure measurement at rest (unit: mmHg).
- Vital function: Electrocardiogram (ECG) [ECG activity witihin one year after index cardiac arrest event.]
12-lead ECG measurement at rest.
- Vital function: Peripheral oxygen saturation [Peripheral oxygen saturation witihin one year after index cardiac arrest event.]
Peripheral oxygen saturation measurement at rest by using pulsoximetry (unit: percent).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients
-
Survival of cardiac arrest
-
Use of extracorporeal cardiopulmonary resuscitation (ECPR) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or ECMELLA (VA-ECMO and left-ventricular Impella micro-axial pump)
Exclusion Criteria:
-
Non-adult patients
-
No cardiac arrest
-
No use of ECPR
-
Inability to comply with follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité - Universitätsmedizin Berlin | Berlin | Germany | 12203 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Director: Carsten Skurk, MD, Charite Univesity
- Principal Investigator: Tharusan Thevathasan, MD, Charite Univesity
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECPR Outpatient Clinic