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

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, WC1V 6AZ
        • Recruiting
        • Intensive Care National Audit & Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Age 18 years old or more; and either
  2. 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
  3. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Critical-illness related cardiac arrest (CIRCA)
Those experiencing a critical illness-related cardiac arrest in a participating adult, general ICU

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
Up to 12 months

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
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
Up to 12 months
Survival status at 12 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
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
Patient quality of life measured through IQCODE questionnaire completion at 3 months
Time Frame: 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
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
12 months
Family member quality of life measured through FROM-16 questionnaire completion at 3 months
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Matt Thomas, MD, North Bristol NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

An anonymised study dataset will be available from ICNARC on request to the Chief Investigator, subject to any necessary approvals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Critical Illness

Subscribe