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

11. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

630

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: post-resuscitation care
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.
Andere Namen:
  • 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.
Sonstiges: post-resuscitation care
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.
Andere Namen:
  • 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.
Sonstiges: post-resuscitation care
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.
Andere Namen:
  • post-ROSC

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intensive Care Unit (ICU) Survival
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hospital discharge status.
Zeitfenster: 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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Azienda Sanitaria Universitaria Integrata del Trentino

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2025

Primärer Abschluss (Tatsächlich)

31. Oktober 2025

Studienabschluss (Tatsächlich)

31. Oktober 2025

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A1007

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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