Outcome of Cardiac Arrest Patients Following Guidelines Implementation Over the Years (IMPACT-ACC)

September 20, 2024 updated by: Mauro Panigada

Implementation of the New Guidelines on the Management of Patients Resuscitated From Cardiac Arrest and Impact on Survival: a Multicenter Retrospective Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Cardiac Arrest

Detailed Description

This study is a retrospective multicenter cohort observational study (two centers involved: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Fondazione IRCCS San Gerardo dei Tintori).

All patients admitted to the Intensive Care Units (ICU) of the hospitals involved in the study from January 1, 2011, to May 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.

Study Type

Observational

Enrollment (Estimated)

693

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Giuseppe Ristagno, MD, PhD
Phone Number: +390255033258
Email: giuseppe.ristagno@unimi.it

Study Contact Backup

Name: Mauro Panigada, MD
Phone Number: +390255033258
Email: mauro.panigada@policlinico.mi.it

Study Locations

Italy
- - Milan, Italy, 20122
    - Recruiting
    - IRCCS Ca' Granda Ospedale Maggiore Policlinico
    - Contact:
      
      Giuseppe Ristagno, MD, PhD
      
      Phone Number: +390255033258
      
      Email: giuseppe.ristagno@unimi.it
    - Contact:
      
      Mauro Panigada, MD
      
      Phone Number: +390255033258
      
      Email: mauro.panigada@policlinico.mi.it
    - Principal Investigator:
      
      Giuseppe Ristagno, MD, PhD
- Monza E Brianza
  - Monza, Monza E Brianza, Italy, 20900
    - Recruiting
    - Fondazione IRCCS San Gerardo dei Tintori
    - Principal Investigator:
      
      Giuseppe Foti, MD
    - Contact:
      
      Giuseppe Foti, MD
      
      Phone Number: +390392339273
      
      Email: g.foti@asst-monza.it
    - Contact:
      
      Emanuele Rezoagli, MD, PhD
      
      Phone Number: +390392339273
      
      Email: emanuele.rezoagli@unimib.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit (ICU) Survival Time Frame: From cardiac arrest date to ICU discharge or death, up to 90 days	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 Time Frame: From cardiac arrest date to ICU discharge or death, up to 90 days	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital discharge status Time Frame: From cardiac arrest date to hospital discharge or death, up to 180 days	To evaluate hospital survival for patients resuscitated from cardiac arrest	From cardiac arrest date to hospital discharge or death, up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauro Panigada

Investigators

Principal Investigator: Giuseppe Ristagno, MD, PhD, IRCCS Cà Granda Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)