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Survival After Cardiac Arrest: How New Treatment Guidelines Changed Patient Outcomes. (RetroAC)

11 giugno 2026 aggiornato da: Alberto Cucino, Azienda Sanitaria Universitaria Integrata del Trentino

Implementation of the New Guidelines on the Management of the Patient Resuscitated From Cardiac Arrest and Impact on Survival: Retrospective Observational Study / Implementazione Delle Nuove Linee Guida Sulla Gestione Del Paziente Rianimato da Arresto Cardiaco ed Impatto Sulla Sopravvivenza: Studio Osservazionale Retrospettivo.

The goal of this retrospective observational cohort study is to evaluate whether the progressive implementation of updated post-cardiac arrest care guidelines has improved survival and neurological recovery in adult patients admitted to the intensive care unit (ICU) after successful resuscitation from cardiac arrest.

Cardiac arrest is one of the leading causes of death worldwide. More than half of patients successfully resuscitated from cardiac arrest die before hospital discharge, largely due to a complex condition known as Post-Cardiac Arrest Syndrome (PCAS), which affects the brain, heart, and all major organ systems. Over the past decade, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) have published updated post-resuscitation care guidelines in 2010, 2015, and 2021, introducing progressively refined treatment recommendations. However, no study has yet evaluated whether the local adoption of these evolving guidelines has translated into measurable improvements in patient outcomes over time.

The main questions this study aims to answer are:

  • Has survival to ICU discharge improved across three successive guideline periods (2010, 2015, and 2021) in adult cardiac arrest patients admitted to the ICU?
  • Has neurological recovery at ICU and hospital discharge improved across the three guideline cohorts?
  • What is the local level of adherence to each set of guideline recommendations, and how does it relate to patient outcomes?
  • What is the impact of individual new interventions introduced by each guideline update on survival and organ function?
  • Do outcomes differ based on whether the cardiac arrest occurred outside or inside the hospital, or based on its underlying cause (cardiac, respiratory, metabolic, toxicological, or traumatic)?

Researchers will compare three patient cohorts defined by the guideline period active at the time of ICU admission - Cohort A (January 2011-December 2015, treated according to 2010 guidelines), Cohort B (January 2016-March 2021, treated according to 2015 guidelines), and Cohort C (April 2021-April 2024, treated according to 2021 guidelines) - to determine whether progressive guideline implementation is associated with improved survival and neurological outcomes over time. Cohort A serves as the reference group.

Participants in this study are adult patients (aged 18 years or older) who experienced cardiac arrest of any cause - whether in or out of hospital - were successfully resuscitated, and were subsequently admitted to ICU at the S. Chiara Hospital in Trento, Italy. Data are collected retrospectively from digitized medical records and cover clinical characteristics, cardiac arrest details, ICU treatments, laboratory and imaging findings, and patient outcomes including survival, length of stay, ventilator-free days, and neurological status at discharge (assessed using the Cerebral Performance Category scale). No interventions are performed as part of this study. Patient data are fully anonymized prior to analysis.

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Effettivo)

630

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Italy
      • Trento, Italy, Italia, 38122
        • Santa Chiara Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients will be selected from the clinical records of the General Intensive Care Unit (ICU1) of S. Chiara Hospital, Trento, Italy, the main teaching hospital of the Azienda Sanitaria Universitaria Integrata del Trentino (ASUIT). S. Chiara Hospital serves as the primary referral center for critical care in the Trentino region and operates in close collaboration with Trentino Emergenza, the regional emergency medical service. Data will be retrieved from the hospital's digitized clinical records system, which is validated on an hourly basis by ward clinical staff, ensuring high data quality and completeness. The study covers a 14-year period (January 2011- December 2024), spanning three successive ERC-ESICM guideline eras. All data will be anonymized.

Descrizione

INCLUSION CRITERIA:

  • Resuscitated from cardiac arrest and subsequently admitted to the intensive care unit (ICU)
  • Age ≥18 years at the time of ICU admission
  • Out-of-hospital or in-hospital cardiac arrest
  • Cardiac arrest of any etiology, including cardiac, respiratory, metabolic, toxicological, and traumatic causes

Exclusion Criteria:

  • Age <18 years at the time of ICU admission (pediatric patients)
  • Not admitted to ICU

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Cohort A - 2010 ERC Guidelines: Post-Cardiac Arrest Patients Managed per 2010 ERC Guidelines
Adult patients (≥18 years) admitted to the general ICU of S. Chiara Hospital, Trento, Italy, between January 2011 and December 2015, following successful resuscitation from in-hospital or out-of-hospital cardiac arrest of any etiology. This cohort was managed according to the 2010 ERC Guidelines, which emphasized post-resuscitation care standardization, therapeutic hypothermia (32-34°C for 24 hours), avoidance of hyperoxia, glucose control (target <180 mg/dL), and primary percutaneous coronary intervention where indicated. This cohort serves as the reference group for comparing survival and neurological recovery outcomes across the three guideline periods.
This study focused on the real-world, bundled implementation of successive ERC-ESICM guideline frameworks - rather than evaluating any single intervention (e.g., targeted temperature management, coronary angiography timing, or neuroprognostication alone). While most existing trials isolate one treatment component, this study captures the cumulative clinical effect of progressively refined, comprehensive post-resuscitation care bundles as delivered in routine ICU practice across three distinct guideline eras (2010, 2015, 2021) over 14 years within a single center. This longitudinal, within-institution design controls for center-level variability, allowing direct comparison of guideline-driven practice evolution and its impact on survival and neurological recovery. No experimental intervention is applied; the exposure of interest is the guideline framework active at the time of each patient's ICU admission.
Altri nomi:
  • post-ROSC
Cohort B - 2015 ERC-ESICM Guidelines: Post-Cardiac Arrest Patients Managed per 2015 ERC Guidelines
Adult patients (≥18 years) admitted to the general ICU of S. Chiara Hospital, Trento, Italy, between January 2016 and March 2021, following successful resuscitation from in-hospital or out-of-hospital cardiac arrest of any etiology. This cohort was managed according to the 2015 ERC-ESICM Guidelines, which introduced a dedicated post-resuscitation care chapter and key updates including: targeted temperature management with an expanded target range (32-36°C), greater emphasis on urgent coronary angiography after cardiac arrest of presumed cardiac cause, and a multimodal neurological prognostication strategy incorporating clinical examination, electrophysiology, biomarkers, and brain imaging.
This study focused on the real-world, bundled implementation of successive ERC-ESICM guideline frameworks - rather than evaluating any single intervention (e.g., targeted temperature management, coronary angiography timing, or neuroprognostication alone). While most existing trials isolate one treatment component, this study captures the cumulative clinical effect of progressively refined, comprehensive post-resuscitation care bundles as delivered in routine ICU practice across three distinct guideline eras (2010, 2015, 2021) over 14 years within a single center. This longitudinal, within-institution design controls for center-level variability, allowing direct comparison of guideline-driven practice evolution and its impact on survival and neurological recovery. No experimental intervention is applied; the exposure of interest is the guideline framework active at the time of each patient's ICU admission.
Altri nomi:
  • post-ROSC
Cohort C - 2021 ERC-ESICM Guidelines: Post-Cardiac Arrest Patients Managed per 2021 ERC Guidelines
Adult patients (≥18 years) admitted to the general ICU of S. Chiara Hospital, Trento, Italy, between April 2021 and April 2024, following successful resuscitation from in-hospital or out-of-hospital cardiac arrest of any etiology. This cohort was managed according to the 2021 ERC-ESICM Guidelines, which introduced further updates including: refined indications for coronary angiography, targeted temperature management with fever avoidance (>37.7°C) for at least 72 hours post-ROSC, updated hemodynamic targets (MAP ≥65 mmHg), stricter glucose control (140-180 mg/dL), preference for levetiracetam or sodium valproate for seizure management, expanded neuroprognosis algorithm, and enhanced guidance on ICU care, long-term follow-up, rehabilitation, and organ donation.
This study focused on the real-world, bundled implementation of successive ERC-ESICM guideline frameworks - rather than evaluating any single intervention (e.g., targeted temperature management, coronary angiography timing, or neuroprognostication alone). While most existing trials isolate one treatment component, this study captures the cumulative clinical effect of progressively refined, comprehensive post-resuscitation care bundles as delivered in routine ICU practice across three distinct guideline eras (2010, 2015, 2021) over 14 years within a single center. This longitudinal, within-institution design controls for center-level variability, allowing direct comparison of guideline-driven practice evolution and its impact on survival and neurological recovery. No experimental intervention is applied; the exposure of interest is the guideline framework active at the time of each patient's ICU admission.
Altri nomi:
  • post-ROSC

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intensive Care Unit (ICU) Survival
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hospital discharge status.
Lasso di tempo: 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
Post-Resuscitation Care Guideline Implementation.
Lasso di tempo: From cardiac arrest date to ICU discharge or death, up to 90 days
To evaluate guideline-recommended intervention adherence.
From cardiac arrest date to ICU discharge or death, up to 90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2025

Completamento primario (Effettivo)

31 ottobre 2025

Completamento dello studio (Effettivo)

31 ottobre 2025

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Data protection regulations and institutional policies limit the dissemination of individual-level data. Therefore, only aggregated results will be made publicly available.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Arresto cardiaco (CA)

Prove cliniche su post-resuscitation care

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