Plain English Summary
Background and study aims
Intensive care units (ICUs) support critically ill patients who would otherwise succumb to their acute illnesses.
Historically the benefit of ICU care to patients has been measured as survival. However, over the last three decades, survival of patients admitted to ICU has improved, so more attention is being focussed on the long-term health problems related to ICU care in survivors. Many of these problems significantly affect patients’ lives. The associations with the ICU stay are poorly understood, partly because they can occur many years later.
This study will investigate one important group of conditions that are common after treatment on an ICU - strokes and diseases of the heart and blood vessels. Evidence from other countries suggests these may be more common after care on an ICU. Disturbances in the heart rhythm are also common during critical illness and separately contribute to the risk of heart attacks and strokes when they occur in the general population. We aim to study their long-term effects post critical illness.
The high number of strokes and heart attacks after ICU care may result from the patients’ underlying illnesses that led to an ICU admission. This may also be due to long-term effects of ICU treatments for low blood pressure and poor circulation during critical illness. Heart problems occurring during an ICU stay such as abnormal heart rhythms may also increase patients’ long-term risks.
Currently, we are unable to identify which patients are at risk of heart attacks and strokes. We need to understand who is at risk. There are well-established treatments to avoid these conditions in the community. This research will help decide who should be considered for these treatments after critical illness.
Who can participate?
Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 01/01/2006 and 01/08/2023.
What does the study involve?
Patient records from 2006 to 2023 will be analysed.
What are the possible benefits and risks of participating?
None
Where is the study run from?
John Radcliffe Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2020 to August 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Robert Hatch, c3study@ndcn.ox.ac.uk
Dr Jonathan Bedford, c3study@ndcn.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Robert Hatch
ORCID ID
http://orcid.org/0000-0002-8176-0831
Contact details
Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 231456
c3study@ndcn.ox.ac.uk
Type
Scientific
Additional contact
Dr Jonathan Bedford
ORCID ID
http://orcid.org/0000-0001-9455-022X
Contact details
Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 231456
c3study@ndcn.ox.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 274165
Study information
Scientific title
The short and long-term cardiovascular consequences of critical illness: The C3 Study
Acronym
C3
Study hypothesis
The aim of this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.
Ethics approval
Approved 10/08/2020, Oxford REC C (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8041; oxfordc.rec@hra.nhs.uk), ref: 20/SC/0105
Study design
Multicentre reterospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available (retrospective study)
Condition
Major adverse cardiovasular events and arrhythmia
Intervention
This is a retrospective cohort study of major adverse cardiovascular events and arrythmias in survivors of critical illness treated on an intensive care unit in the UK.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured using electronic healthcare records at 5 years post-discharge from ICU:
1. Mortality
2. Major adverse cardiovascular and vascular events
3. Arrhythmia
Secondary outcome measures
Hospital re-admission measured using electronic healthcare records at 5 years post-discharge from ICU
Overall trial start date
01/08/2020
Overall trial end date
01/08/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 01/01/2006 and 01/08/2023.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80,000
Participant exclusion criteria
1. Patients that have informed their participating site that they do not wish their electronic records would be used for future research
2. Patients who inform us directly that they don’t wish their records used in this research study
Recruitment start date
01/09/2020
Recruitment end date
01/08/2023
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford University Hospital NHS Foundation Trust
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
ccrg@ndcn.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Multiple peer reviewed open access publications.
IPD sharing statement:
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data sharing agreements do not allow for the release of the data. The data will be held by the research group and requests for access will be considered on a case by case basis.
Intention to publish date
01/08/2023
Participant level data
Available on request
Basic results (scientific)
Publication list