Evaluation of eCPR Survivors

Evaluation of Cardio-pulmonary, Physcial and Neuro-psychiatric Function in Patients Who Survived a Therapy-refractory Cardiac Arrest With Extracorporeal Cardiopulmonary Resuscitation.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Cardiac Arrest; Cardiopulmonary Resuscitation; Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Device: VA-ECMO or ECMELLA

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Tharusan Thevathasan, MD; Phone Number: +49 30 450 613 687; Email: tharusan.thevathasan@charite.de
• Study Contact Backup: Name: Carsten Skurk, MD; Phone Number: +49 30 450 513 725; Email: carsten.skurk@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité - Universitätsmedizin Berlin
    • Contact: Carsten Skurk, MD; Phone Number: +49 30 450 513 725; Email: carsten.skurk@charite.de
    • Contact: Tharusan Thevathasan, MD; Phone Number: +49 1577 440 7864; Email: tharusan.thevathasan@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients who suffered from cardiac arrest and were treated with ECPR.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction (LVEF)	LVEF measured with transthoracic echocardiography.	LVEF witihin one year after index cardiac arrest event.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	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].	Cognitive function witihin one year after index cardiac arrest event.
Sign and symptoms of heart failure	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].	Sign and symptoms of heart failure witihin one year after index cardiac arrest event.
Activity of daily living (ADL)	ADL measured with a standardized questionnaire and following estbalished score: Barthel index [0-100 points; higher score means better outcome].	ADL witihin one year after index cardiac arrest event.
Comorbidity level	Comorbidity level measured with following established score: Charlson comorbidity index [0-24 points; lower score means better outcome].	Comorbidity level witihin one year after index cardiac arrest event.
Number of cardiovascular medications	Number of cardiovascular medications documented with a standardized questionnaire.	Number of cardiovascular medication witihin one year after index cardiac arrest event.
Cardiac stress test: Ergometry	Quantitative test to evaluate cardiopulmonary exercise tolerance and physical capacity by using a bicycle.	Physical function witihin one year after index cardiac arrest event.
Cardiac stress test: Walking distance	Quantitative test to evaluate endurance and aerobic capacity by walking for six minutes (six minute walk test).	Physical function witihin one year after index cardiac arrest event.
Vital function: Blood pressure	Non-invasive blood pressure measurement at rest (unit: mmHg).	Blood pressure witihin one year after index cardiac arrest event.
Vital function: Electrocardiogram (ECG)	12-lead ECG measurement at rest.	ECG activity witihin one year after index cardiac arrest event.
Vital function: Peripheral oxygen saturation	Peripheral oxygen saturation measurement at rest by using pulsoximetry (unit: percent).	Peripheral oxygen saturation witihin one year after index cardiac arrest event.

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Universitätsklinikum Düsseldorf
• Investigators: Study Director: Carsten Skurk, MD, Charite Univesity; Principal Investigator: Tharusan Thevathasan, MD, Charite Univesity

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Heart Arrest; Shock, Cardiogenic
• Other Study ID Numbers: ECPR Outpatient Clinic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No