Menu
Recruiting NCT05132387

Wroclaw Out-Of-Hospital Cardiac Arrest Registry

Observational Out-Of-Hospital Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECMO assisted CPR in out-of-hospital cardiac arrest.
Who it may be relevant to
Registry conditions: Out-Of-Hospital Cardiac Arrest. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.

Detailed description

Patients with out-of-hospital cardiac arrest included in the program will be treated with extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation (CPR) with additional invasive procedures including coronary/pulmonary angiography and intervention. This type of treatment was not provided in institutionalized fashion in Wroclaw, Poland. Implementation of this program should improve survival in out-of-hospital cardiac arrest patients, which currently is less than 10%.

Interventions

  • Other ECMO assisted CPR in out-of-hospital cardiac arrest
    Patients included in the registry will be transferred during LUCAS assisted CPR by the Wroclaw Emergency Medical Services to the Emergency Department of the Wroclaw University Hospital where blood gasses will be assessed. If two or more of the following: end-tidal carbon dioxide (CO2) \> 10 mm Hg, arterial partial pressure of oxygen (PaO2) \>50 mm Hg or oxygen saturation \>85%, and lactic acid \<18 mmol/L will be fulfilled patient will be further transferred to the Cardiac Catheterization Labora

Primary outcome measures

  • mortality [Time frame: 1 month]
Secondary outcome measures (1)
  • degree of disability [Time frame: 3 and 6 months after index event]

Eligibility criteria

Inclusion criteria

  • Age < 60 years
  • witnessed sudden cardiac arrest with immediate CPR
  • supposed cardiac cause of the event
  • ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) at first medical contact with 3 unsuccessful defibrillations (no ROSC)
  • CPR conducted with Lund University Cardiopulmonary Assist System (LUCAS™)
  • Estimated transfer time from the scene to the Emergency Department < 30 minutes.
  • End tidal carbon dioxide (ETCO2) > 10 mmHg

Exclusion criteria

  • Total presumed time from 112 call to ECMO implantation longer than 60 minutes
  • Age < 18 years old or > 60 years old;
  • Non-shockable initial rhythm
  • Unavailability of the automated CPR device
  • Unavailability of the catheterisation laboratory
  • Severe concomitant illness with decreased life expectancy
  • Severe body injury
  • Severe active bleeding
  • Drowning
  • Terminal cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Wroclaw University Hostpital — Wroclaw

Publications

  • Sip M, Puslecki M, Klosiewicz T, Zalewski R, Dabrowski M, Ligowski M, Goszczynska E, Paprocki C, Grygier M, Lesiak M, Jemielity M, Perek B. A concept for the development of a pioneer regional Out-of-Hospital Cardiac Arrest Program to improve patient outcomes. Kardiol Pol. 2020 Sep 25;78(9):875-881. doi: 10.33963/KP.15433. Epub 2020 Jun 16. PMID 32550730
  • Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial PMID 33197396

Identifiers

NCT: NCT05132387 · 327/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗