- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04219384
Остановка сердца, связанная с критическим заболеванием (CIRCA) (CIRCA)
Остановка сердца, связанная с критическим заболеванием (CIRCA): исследование частоты и исхода остановки сердца в отделениях интенсивной терапии в Соединенном Королевстве
CIRCA aims to determine the incidence and outcomes of in-hospital cardiac arrest (IHCA) in UK intensive care units (ICUs) and explore associated risk factors with ICU and hospital survival and quality of survival following hospital discharge.
Обзор исследования
Статус
Условия
Подробное описание
Cardiac arrest is often categorised by location, out-of-hospital or in-hospital (IHCA), as there are important differences in population characteristics and aetiology. The National Cardiac Arrest Audit (NCAA) was established to audit resuscitation teams in response to IHCA, and collects information about patient characteristics, resuscitation processes, and patient outcomes. However, it does not audit IHCAs that are not attended by the resuscitation team.
Critically ill patients managed in ICUs are experiencing failure of one or more organs and therefore more intensive and invasive therapies are needed to support these failing organs. As a result, ICUs have higher nursing and medical staffing ratios, and monitoring is usually continuous. Moreover, the skill mix of the multidisciplinary team is geared to advanced life support. Thus, the risk of cardiac arrest occurring, the involvement (or not) of the resuscitation team, and the probability of return of spontaneous circulation are all likely to be different to other IHCAs.
Accurate data on cardiac arrests in ICU are lacking and the investigators do not know how many IHCA occur in ICU in the UK, nor is the impact of an IHCA in ICU on outcome known. In addition, it is not known if these IHCAs in ICUs represent an unavoidable consequence of critical illness or, more importantly, whether they can be predicted and/or prevented.
CIRCA is a prospective, multi-centre observational cohort study nested in the Case Mix Programme (CMP) and NCAA national clinical audits. The investigators aim to determine the incidence and outcomes of IHCA in UK ICUs and explore associated risk factors with ICU and hospital survival and quality of survival following hospital discharge.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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-
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London, Соединенное Королевство, WC1V 6AZ
- Intensive Care National Audit & Research Centre
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adults having cardiac arrest (defined as receipt of chest compressions and/or defibrillation) after admission to an Intensive Care Unit (ICU) participating in the Case Mix Programme in a hospital participating in the National Cardiac Arrest Audit
Описание
Inclusion Criteria:
- Age 18 years old or more; and either
- Cardiac arrest (defined as receipt of chest compressions or defibrillation) occurring while in-hospital and within intensive care (defined as either ICU, HDU or combined ICU/HDU); or
- Family member of a patient surviving to discharge from intensive care after a cardiac arrest within ICU
Exclusion Criteria:
There are no exclusion criteria
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
|---|
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Critical-illness related cardiac arrest (CIRCA)
Those experiencing a critical illness-related cardiac arrest in a participating adult, general ICU |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence
Временное ограничение: Up to 12 months
|
Incidence of critical illness related cardiac arrest |
Up to 12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Subsequent incidence of in-hospital cardiac arrest
Временное ограничение: Up to 12 months
|
Subsequent incidence of in-hospital cardiac arrest obtained through data linkage to the National Cardiac Arrest Audit |
Up to 12 months
|
|
Survival status at hospital discharge
Временное ограничение: Up to 12 months
|
Survival status at hospital discharge obtained from data linkage to the Case Mix Programme |
Up to 12 months
|
|
Survival status at 12 months
Временное ограничение: 12 months
|
Survival status at 12 months obtained from data linkage to NHS Digital |
12 months
|
|
Patient quality of life measured through EQ-5D-5L questionnaire completion at 3 months
Временное ограничение: 3 months
|
Patient quality of life measured through completion of EuroQol 5 Dimension (5 level) questionnaire at 3 months following critical illness related cardiac arrest |
3 months
|
|
Patient quality of life measured through EQ-5D-5L questionnaire completion at 6 months
Временное ограничение: 6 months
|
Patient quality of life measured through completion of EuroQol 5 Dimension (5 level) questionnaire at 6 months following critical illness related cardiac arrest |
6 months
|
|
Patient quality of life measured through EQ-5D-5L questionnaire completion at 12 months
Временное ограничение: 12 months
|
Patient quality of life measured through completion of EuroQol 5 Dimension (5 level) questionnaire at 12 months following critical illness related cardiac arrest |
12 months
|
|
Patient quality of life measured through IQCODE questionnaire completion at 3 months
Временное ограничение: 3 months
|
Patient quality of life measured through completion of Informant Questionnaire on Cognitive Decline in the Elderly questionnaire at 3 months following critical illness related cardiac arrest |
3 months
|
|
Patient quality of life measured through IQCODE questionnaire completion at 6 months
Временное ограничение: 6 months
|
Patient quality of life measured through completion of Informant Questionnaire on Cognitive Decline in the Elderly questionnaire at 6 months following critical illness related cardiac arrest |
6 months
|
|
Patient quality of life measured through IQCODE questionnaire completion at 12 months
Временное ограничение: 12 months
|
Patient quality of life measured through completion of Informant Questionnaire on Cognitive Decline in the Elderly questionnaire at 12 months following critical illness related cardiac arrest |
12 months
|
|
Family member quality of life measured through FROM-16 questionnaire completion at 3 months
Временное ограничение: 3 months
|
Quality of life of family member of patients surviving critical illness related cardiac arrest measured through completion of Family Reported Outcome Measures 16 questionnaire at 3 months following patient arrest |
3 months
|
|
Family member quality of life measured through FROM-16 questionnaire completion at 6 months
Временное ограничение: 6 months
|
Quality of life of family member of patients surviving critical illness related cardiac arrest measured through completion of Family Reported Outcome Measures 16 questionnaire at 6 months following patient arrest |
6 months
|
|
Family member quality of life measured through FROM-16 questionnaire completion at 12 months
Временное ограничение: 12 months
|
Quality of life of family member of patients surviving critical illness related cardiac arrest measured through completion of Family Reported Outcome Measures 16 questionnaire at 12 months following patient arrest |
12 months
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Matt Thomas, MD, North Bristol NHS Trust
Публикации и полезные ссылки
Общие публикации
- Darnell R, Broomhall J, Newell C, Gendall E, Harrison D, Rowan K, Doidge J, Mouncey P, Gould D, Thomas M. Critical Illness Related Cardiac Arrest (CIRCA): a prospective investigation of the incidence and outcome of cardiac arrest within intensive care units in the United Kingdom. Resuscitation. 2026 Feb;219:110933. doi: 10.1016/j.resuscitation.2025.110933. Epub 2025 Dec 22.
- Darnell R, Newell C, Edwards J, Gendall E, Harrison D, Sprinckmoller S, Mouncey P, Gould D, Thomas M. Critical illness-related cardiac arrest: Protocol for an investigation of the incidence and outcome of cardiac arrest within intensive care units in the United Kingdom. J Intensive Care Soc. 2022 Nov;23(4):493-497. doi: 10.1177/17511437211055899. Epub 2022 Mar 13.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ICNARC/02/11/2019
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
An anonymised study dataset will be available from ICNARC on request to the Chief Investigator, subject to any necessary approvals
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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