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Clinical Trials/NCT05339854
NCT05339854
Not yet recruiting
Not Applicable

Evaluation of Cardio-pulmonary, Physcial and Neuro-psychiatric Function in Patients Who Survived a Therapy-refractory Cardiac Arrest With Extracorporeal Cardiopulmonary Resuscitation.

Charite University, Berlin, Germany1 site in 1 country30 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Charite University, Berlin, Germany
Enrollment
30
Locations
1
Primary Endpoint
Left ventricular ejection fraction (LVEF)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tharusan Thevathasan

Principal Investigator

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Left ventricular ejection fraction (LVEF)

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

LVEF measured with transthoracic echocardiography.

Secondary Outcomes

  • Vital function: Blood pressure(Blood pressure witihin one year after index cardiac arrest event.)
  • Vital function: Peripheral oxygen saturation(Peripheral oxygen saturation witihin one year after index cardiac arrest event.)
  • Vital function: Electrocardiogram (ECG)(ECG activity witihin one year after index cardiac arrest event.)
  • 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.)
  • Cardiac stress test: Ergometry(Physical function witihin one year after index cardiac arrest event.)
  • Cardiac stress test: Walking distance(Physical function witihin one year after index cardiac arrest event.)

Study Sites (1)

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