Critical Illness Related Cardiac Arrest (CIRCA)

Critical Illness Clinical Trial

— CIRCA  

Official title:

Critical Illness Related Cardiac Arrest (CIRCA): an Investigation of the Incidence and Outcome of Cardiac Arrest Within Intensive Care Units in the United Kingdom

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219384
• Other study ID #: ICNARC/02/11/2019
• Status: Recruiting
• Start date: January 27, 2020
• Est. completion date: July 2022

Study information

• Verified date: October 2020
• Source: Intensive Care National Audit & Research Centre
• Contact: Doug Gould
• Phone: 02072699277
• Email: doug.gould[@]icnarc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: July 2022
• Est. primary completion date: June 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Heart Arrest

Locations

Country	Name	City	State
United Kingdom	Intensive Care National Audit & Research Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Intensive Care National Audit & Research Centre	North Bristol NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence	Incidence of critical illness related cardiac arrest	Up to 12 months
Secondary	Subsequent incidence of in-hospital cardiac arrest	Subsequent incidence of in-hospital cardiac arrest obtained through data linkage to the National Cardiac Arrest Audit	Up to 12 months
Secondary	Survival status at hospital discharge	Survival status at hospital discharge obtained from data linkage to the Case Mix Programme	Up to 12 months
Secondary	Survival status at 12 months	Survival status at 12 months obtained from data linkage to NHS Digital	12 months
Secondary	Patient quality of life measured through EQ-5D-5L questionnaire completion at 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
Secondary	Patient quality of life measured through EQ-5D-5L questionnaire completion at 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
Secondary	Patient quality of life measured through EQ-5D-5L questionnaire completion at 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
Secondary	Patient quality of life measured through IQCODE questionnaire completion at 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
Secondary	Patient quality of life measured through IQCODE questionnaire completion at 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
Secondary	Patient quality of life measured through IQCODE questionnaire completion at 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
Secondary	Family member quality of life measured through FROM-16 questionnaire completion at 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
Secondary	Family member quality of life measured through FROM-16 questionnaire completion at 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
Secondary	Family member quality of life measured through FROM-16 questionnaire completion at 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