- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219384
Critical Illness Related Cardiac Arrest (CIRCA) (CIRCA)
Critical Illness Related Cardiac Arrest (CIRCA): an Investigation of the Incidence and Outcome of Cardiac Arrest Within Intensive Care Units in the United Kingdom
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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London, United Kingdom, WC1V 6AZ
- Recruiting
- Intensive Care National Audit & Research Centre
-
Contact:
- ICNARC CTU
- Phone Number: 02072699277
- Email: circa@icnarc.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Critical-illness related cardiac arrest (CIRCA)
Those experiencing a critical illness-related cardiac arrest in a participating adult, general ICU
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence
Time Frame: Up to 12 months
|
Incidence of critical illness related cardiac arrest
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Up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subsequent incidence of in-hospital cardiac arrest
Time Frame: Up to 12 months
|
Subsequent incidence of in-hospital cardiac arrest obtained through data linkage to the National Cardiac Arrest Audit
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Up to 12 months
|
|
Survival status at hospital discharge
Time Frame: Up to 12 months
|
Survival status at hospital discharge obtained from data linkage to the Case Mix Programme
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Up to 12 months
|
|
Survival status at 12 months
Time Frame: 12 months
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Survival status at 12 months obtained from data linkage to NHS Digital
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12 months
|
|
Patient quality of life measured through EQ-5D-5L questionnaire completion at 3 months
Time Frame: 3 months
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Patient quality of life measured through completion of EuroQol 5 Dimension (5 level) questionnaire at 3 months following critical illness related cardiac arrest
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3 months
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Patient quality of life measured through EQ-5D-5L questionnaire completion at 6 months
Time Frame: 6 months
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Patient quality of life measured through completion of EuroQol 5 Dimension (5 level) questionnaire at 6 months following critical illness related cardiac arrest
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6 months
|
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Patient quality of life measured through EQ-5D-5L questionnaire completion at 12 months
Time Frame: 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
|
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Patient quality of life measured through IQCODE questionnaire completion at 3 months
Time Frame: 3 months
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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
Time Frame: 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
Time Frame: 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
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12 months
|
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Family member quality of life measured through FROM-16 questionnaire completion at 3 months
Time Frame: 3 months
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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
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3 months
|
|
Family member quality of life measured through FROM-16 questionnaire completion at 6 months
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matt Thomas, MD, North Bristol NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICNARC/02/11/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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