Survival After Cardiac Arrest: How New Treatment Guidelines Changed Patient Outcomes. (RetroAC)
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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Italy
-
Trento、Italy、イタリア、38122
- Santa Chiara Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
|
|
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.
他の名前：
|
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intensive Care Unit (ICU) Survival
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital discharge status.
時間枠：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.
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- A1007
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。