NCT06608771

Brief Summary

The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. During this time period, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

August 8, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

Out-Of-Hospital Cardiac ArrestIn-Hospital Cardiac ArrestGuidelines ImplementationResuscitation

Outcome Measures

Primary Outcomes (2)

  • Intensive Care Unit (ICU) Survival

    To evaluate ICU survival for patients resuscitated from cardiac arrest

    From cardiac arrest date to ICU discharge or death, up to 90 days

  • Neurological recovery at ICU discharge

    ICU Survival with Cerebral Performance Category (CPC) score of 1 or 2

    From cardiac arrest date to ICU discharge or death, up to 90 days

Secondary Outcomes (1)

  • Hospital discharge status

    From cardiac arrest date to hospital discharge or death, up to 180 days

Study Arms (1)

Out-of-hospital cardiac arrest (OHCA) and In-hospital cardiac arrest (IHCA) patients

The study population includes all adult patients resuscitated from cardiac arrest and subsequently admitted to the Intensive Care Unit over a 14-year-period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients resuscitated from cardiac arrest and admitted to ICU over a 14-year-period

You may qualify if:

  • Patients resuscitated from cardiac arrest and admitted to intensive care unit
  • Age ≥ 18 years
  • Out-of-hospital and in-hospital cardiac arrest
  • Cardiac arrest of any etiology

You may not qualify if:

  • Pediatric patients (\<18 years)
  • Patients not admitted to one of the aforementioned intensive care units.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

RECRUITING

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Giuseppe Ristagno, MD, PhD

    IRCCS Cà Granda Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Ristagno, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, Head of the Intensive Care Unit, Department of Anaesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Study Record Dates

First Submitted

August 8, 2024

First Posted

September 23, 2024

Study Start

July 26, 2024

Primary Completion

December 31, 2025

Study Completion

March 30, 2026

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations