Evaluation of eCPR Survivors

NCT05339854 | Unknown

• 1 other identifier: ECPR Outpatient Clinic
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF)

  LVEF measured with transthoracic echocardiography.

  LVEF witihin one year after index cardiac arrest event.

Secondary Outcomes (10)

• Cognitive function

  Cognitive function witihin one year after index cardiac arrest event.

• Sign and symptoms of heart failure

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

• Activity of daily living (ADL)

  ADL witihin one year after index cardiac arrest event.

• Comorbidity level

  Comorbidity level witihin one year after index cardiac arrest event.

• Number of cardiovascular medications

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

Study Arms (1)

ECPR survivor

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University Düsseldorf: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw: Sodium, Potassium, Chloride, Calcium, Magnesium, Creatinine, Urea, Uric acid, Bilirubin, Cholesterol (total, HDL, LDL), Triglyceride, Lipoprotein (a), HbA1c, NT-proBNP, Creatinkinase (CK), CK-MB, Myoglobin, ALT, AST, Gamma-GT, Alkaline phosphatase, GLDH, Lipase, LDH, CRP, Procalcitonin, Albumin, Iron, Ferritin, Transferrin, Transferrin saturation, Haptoglobin, Free hemoglobin, Complete blood count, Quick, PTT, TSH, T4, T3, Cortisol, venous arterial blood gas.

MeSH Terms

Conditions

Heart Arrest; Myocardial Infarction; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Carsten Skurk, MD

  Charite Univesity

  STUDY DIRECTOR

• Tharusan Thevathasan, MD

  Charite Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tharusan Thevathasan, MD

CONTACT

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

Carsten Skurk, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 21, 2022
• Study Start: June 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)