Condition category
Circulatory System
Date applied
03/09/2020
Date assigned
10/09/2020
Last edited
04/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.c3study.org

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

https://www.ox.ac.uk

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

Publication citations

Additional files

Editorial Notes

04/09/2020: Trial’s existence confirmed by NHS HRA.