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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05339854

Enrollment

Registered

2022-04-21

Start date

2023-06-01

Completion date

2024-03-30

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Cardiogenic Shock, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation Complication, Myocardial Infarction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Cognitive function	Cognitive function witihin one year after index cardiac arrest event.	Cognitive function measured with a standardized questionnaire and following established scores: 1. Mini-mental-status-test \[0-30 points; higher score means better outcome\], 2. Cerebral Performance Categories Scale \[1-5; lower score means better outcome\].
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).
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.

Countries

Germany

Contacts

Primary ContactTharusan Thevathasan, MD

tharusan.thevathasan@charite.de+49 30 450 613 687

Backup ContactCarsten Skurk, MD

carsten.skurk@charite.de+49 30 450 513 725

Outcome results