ClinicalTrials.gg
Status unknownNCT05339854Updated May 16, 2023

Evaluation of eCPR Survivors

An observational study in Cardiac Arrest, Cardiopulmonary Resuscitation and Extracorporeal Membrane Oxygenation Complication, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Charite University, Berlin, Germany · Observational

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Cardiac Arrest
  • Cardiopulmonary Resuscitation
  • Extracorporeal Membrane Oxygenation Complication
  • Myocardial Infarction
  • Cardiogenic Shock
03

In context

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 30 is below the median of 196 across 394 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-adult patients
  • No cardiac arrest
  • No use of ECPR
  • Inability to comply with follow-up
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • ECPR survivor

    Adult patient who survived therapy-refractory cardiac arrest with extracorporeal cardiopulmonary resuscitation (ECPR).

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What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction (LVEF)

    LVEF measured with transthoracic echocardiography.

    Time frame: LVEF witihin one year after index cardiac arrest event.

Secondary outcomes

  1. Cognitive function

    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 \[1-5; lower score means better outcome\].

    Time frame: Cognitive function witihin one year after index cardiac arrest event.

  2. 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 \[0-100 points; higher score means better outcome\].

    Time frame: Sign and symptoms of heart failure witihin one year after index cardiac arrest event.

  3. Activity of daily living (ADL)

    ADL measured with a standardized questionnaire and following estbalished score: Barthel index \[0-100 points; higher score means better outcome\].

    Time frame: ADL witihin one year after index cardiac arrest event.

  4. Comorbidity level

    Comorbidity level measured with following established score: Charlson comorbidity index \[0-24 points; lower score means better outcome\].

    Time frame: Comorbidity level witihin one year after index cardiac arrest event.

  5. Number of cardiovascular medications

    Number of cardiovascular medications documented with a standardized questionnaire.

    Time frame: Number of cardiovascular medication witihin one year after index cardiac arrest event.

  6. Cardiac stress test: Ergometry

    Quantitative test to evaluate cardiopulmonary exercise tolerance and physical capacity by using a bicycle.

    Time frame: Physical function witihin one year after index cardiac arrest event.

  7. Cardiac stress test: Walking distance

    Quantitative test to evaluate endurance and aerobic capacity by walking for six minutes (six minute walk test).

    Time frame: Physical function witihin one year after index cardiac arrest event.

  8. Vital function: Blood pressure

    Non-invasive blood pressure measurement at rest (unit: mmHg).

    Time frame: Blood pressure witihin one year after index cardiac arrest event.

  9. Vital function: Electrocardiogram (ECG)

    12-lead ECG measurement at rest.

    Time frame: ECG activity witihin one year after index cardiac arrest event.

  10. Vital function: Peripheral oxygen saturation

    Peripheral oxygen saturation measurement at rest by using pulsoximetry (unit: percent).

    Time frame: Peripheral oxygen saturation witihin one year after index cardiac arrest event.

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05339854
Collaborators
University Düsseldorf
Responsible party
Tharusan Thevathasan (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 21, 2022
Start date
Jun 1, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Mar 30, 2024 (estimated)
Last update
May 16, 2023

Study contacts

Tharusan Thevathasan, MD
Contact
tharusan.thevathasan@charite.de
+49 30 450 613 687
Carsten Skurk, MD
Contact
carsten.skurk@charite.de
+49 30 450 513 725
Carsten Skurk, MD
study director · Charite Univesity
Tharusan Thevathasan, MD
principal investigator · Charite Univesity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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