Cardiac ArrestNCT05339854
Evaluation of eCPR Survivors
An observational study of Cardiac Arrest and Cardiopulmonary Resuscitation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation Complication
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who suffered from cardiac arrest and were treated with ECPR.
Who may be able to join
- 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)
Who cannot join
- Non-adult patients
- No cardiac arrest
- No use of ECPR
- Inability to comply with follow-up
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, 12203
Tharusan Thevathasan, MD, +49 1577 440 7864, tharusan.thevathasan@charite.de
Carsten Skurk, MD, +49 30 450 513 725, carsten.skurk@charite.de
About this study
Official title: 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.
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation Complication, Myocardial Infarction, Cardiogenic Shock
- Medical subject headings
- Heart Arrest, Myocardial Infarction, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ECPR survivor | Adult patient who survived therapy-refractory cardiac arrest with extracorporeal cardiopulmonary resuscitation (ECPR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
LVEF measured with transthoracic echocardiography.
Measured: LVEF witihin one year after index cardiac arrest event.
Secondary outcomes (10)
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].
Measured: 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].
Measured: 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].
Measured: 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].
Measured: Comorbidity level witihin one year after index cardiac arrest event.
Number of cardiovascular medications
Number of cardiovascular medications documented with a standardized questionnaire.
Measured: 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.
Measured: 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).
Measured: Physical function witihin one year after index cardiac arrest event.
Vital function: Blood pressure
Non-invasive blood pressure measurement at rest (unit: mmHg).
Measured: Blood pressure witihin one year after index cardiac arrest event.
Vital function: Electrocardiogram (ECG)
12-lead ECG measurement at rest.
Measured: 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).
Measured: Peripheral oxygen saturation witihin one year after index cardiac arrest event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jun 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Düsseldorf
- Responsible party
- Principal investigator, Tharusan Thevathasan, Charite University, Berlin, Germany
- Investigators
- Carsten Skurk, MD, Study director, Charite UnivesityTharusan Thevathasan, MD, Principal investigator, Charite Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339854
- Sponsor's protocol ID
- ECPR Outpatient Clinic
- Status last verified
- May 2023
- First submitted
- 10 Apr 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardio-pulmonary, Physcial and Neuro-psychiatric Function in Patients Who Survived a Therapy-refractory Cardiac Arrest With Extracorporeal Cardiopulmonary Resuscitation.
- ClinicalTrials.gov ID
- NCT05339854
- Acronym / sponsor ID
- ECPR Outpatient Clinic
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation Complication, Myocardial Infarction, Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Düsseldorf
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECPR survivor | – | –Adult patient who survived therapy-refractory cardiac arrest with extracorporeal cardiopulmonary resuscitation (ECPR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who suffered from cardiac arrest and were treated with ECPR.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Non-adult patients
- No cardiac arrest
- No use of ECPR
- Inability to comply with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: LVEF witihin one year after index cardiac arrest event.
LVEF measured with transthoracic echocardiography.
10 secondary outcomes
Cognitive function
Time frame: Cognitive function witihin one year after index cardiac arrest event.
Sign and symptoms of heart failure
Time frame: Sign and symptoms of heart failure witihin one year after index cardiac arrest event.
Activity of daily living (ADL)
Time frame: ADL witihin one year after index cardiac arrest event.
Comorbidity level
Time frame: Comorbidity level witihin one year after index cardiac arrest event.
Number of cardiovascular medications
Time frame: Number of cardiovascular medication witihin one year after index cardiac arrest event.
Cardiac stress test: Ergometry
Time frame: Physical function witihin one year after index cardiac arrest event.
Cardiac stress test: Walking distance
Time frame: Physical function witihin one year after index cardiac arrest event.
Vital function: Blood pressure
Time frame: Blood pressure witihin one year after index cardiac arrest event.
Vital function: Electrocardiogram (ECG)
Time frame: ECG activity witihin one year after index cardiac arrest event.
Vital function: Peripheral oxygen saturation
Time frame: Peripheral oxygen saturation witihin one year after index cardiac arrest event.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skurk, MD study director
Charite Univesity
Tharusan Thevathasan, MD principal investigator
Charite Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Cardiopulmonary Resuscitation, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tharusan Thevathasan, MD (+49 30 450 613 687, tharusan.thevathasan@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: LVEF witihin one year after index cardiac arrest event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.