- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649889
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Italy
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Trento, Italy, 이탈리아, 38122
- Santa Chiara Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
다른 이름들:
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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.
다른 이름들:
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intensive Care Unit (ICU) Survival
기간: From cardiac arrest date to ICU discharge or death, up to 90 days
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To evaluate ICU survival for patients resuscitated from cardiac arrest.
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From cardiac arrest date to ICU discharge or death, up to 90 days
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Neurological Recovery at ICU Discharge
기간: From cardiac arrest date to ICU discharge or death, up to 90 days
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ICU Survival with Cerebral Performance Category (CPC) score of 1 or 2
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From cardiac arrest date to ICU discharge or death, up to 90 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospital discharge status.
기간: From cardiac arrest date to hospital discharge or death, up to 180 days
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To evaluate hospital survival for patients resuscitated from cardiac arrest.
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From cardiac arrest date to hospital discharge or death, up to 180 days
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Post-Resuscitation Care Guideline Implementation.
기간: From cardiac arrest date to ICU discharge or death, up to 90 days
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To evaluate guideline-recommended intervention adherence.
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From cardiac arrest date to ICU discharge or death, up to 90 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A1007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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