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

11 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

630

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: 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.
Inne nazwy:
  • 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.
Inny: 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.
Inne nazwy:
  • 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.
Inny: 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.
Inne nazwy:
  • post-ROSC

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Intensive Care Unit (ICU) Survival
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hospital discharge status.
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Azienda Sanitaria Universitaria Integrata del Trentino

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2025

Zakończenie podstawowe (Rzeczywisty)

31 października 2025

Ukończenie studiów (Rzeczywisty)

31 października 2025

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A1007

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zatrzymanie krążenia (CA)

Badania kliniczne na post-resuscitation care

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