Clinical trial NCT05339854: Evaluation of eCPR Survivors
Official title: Evaluation of Cardio-pulmonary, Physcial and Neuro-psychiatric Function in Patients Who Survived a Therapy-refractory Cardiac Arrest With Extracorporeal Cardiopulmonary Resuscitation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Cardiopulmonary Resuscitation
Extracorporeal Membrane Oxygenation Complication
Myocardial Infarction
Cardiogenic Shock
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Düsseldorf
First posted: 2022-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who suffered from cardiac arrest and were treated with ECPR.

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.


Eligibility 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: LVEF witihin one year after index cardiac arrest event.
Secondary outcomes:
measure: Cognitive function
timeFrame: Cognitive function witihin one year after index cardiac arrest event.
measure: Sign and symptoms of heart failure
timeFrame: Sign and symptoms of heart failure witihin one year after index cardiac arrest event.
measure: Activity of daily living (ADL)
timeFrame: ADL witihin one year after index cardiac arrest event.
measure: Comorbidity level
timeFrame: Comorbidity level witihin one year after index cardiac arrest event.
measure: Number of cardiovascular medications
timeFrame: Number of cardiovascular medication witihin one year after index cardiac arrest event.
measure: Cardiac stress test: Ergometry
timeFrame: Physical function witihin one year after index cardiac arrest event.
measure: Cardiac stress test: Walking distance
timeFrame: Physical function witihin one year after index cardiac arrest event.
measure: Vital function: Blood pressure
timeFrame: Blood pressure witihin one year after index cardiac arrest event.
measure: Vital function: Electrocardiogram (ECG)
timeFrame: ECG activity witihin one year after index cardiac arrest event.
measure: Vital function: Peripheral oxygen saturation
timeFrame: Peripheral oxygen saturation witihin one year after index cardiac arrest event.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite Univesity
name: Carsten Skurk, MD
role: STUDY_DIRECTOR
affiliation: Charite Univesity
name: Tharusan Thevathasan, MD
role: PRINCIPAL_INVESTIGATOR
References: