Evaluation of eCPR Survivors

Not yet recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication; Cardiac Arrest; Cardiopulmonary Resuscitation; Cardiogenic Shock; Myocardial Infarction

• Registration Number: NCT05339854
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16
• Study Start: 2023-06-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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: 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).
Vital function: Electrocardiogram (ECG)	ECG activity witihin one year after index cardiac arrest event.	12-lead ECG measurement at rest.
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 \[1-5; lower score means better outcome\].
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).

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany