The short and long-term consequences of critical illness on the heart and blood vessels

ISRCTN ISRCTN15905609
DOI https://doi.org/10.1186/ISRCTN15905609
IRAS number 274165
Secondary identifying numbers IRAS 274165
Submission date
03/09/2020
Registration date
10/09/2020
Last edited
04/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Robert Hatch
Scientific

Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0002-8176-0831
Phone +44 (0)1865 231456
Email c3study@ndcn.ox.ac.uk
Dr Jonathan Bedford
Scientific

Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0001-9455-022X
Phone +44 (0)1865 231456
Email c3study@ndcn.ox.ac.uk

Study information

Study designMulticentre reterospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet No participant information sheet available (retrospective study)
Scientific titleThe short and long-term cardiovascular consequences of critical illness: The C3 Study
Study acronymC3
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedMajor adverse cardiovasular events and arrhythmia
InterventionThis 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 typeOther
Primary outcome measureMeasured using electronic healthcare records at 5 years post-discharge from ICU:
1. Mortality
2. Major adverse cardiovascular and vascular events
3. Arrhythmia
Secondary outcome measuresHospital re-admission measured using electronic healthcare records at 5 years post-discharge from ICU
Overall study start date01/08/2020
Completion date01/08/2023

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80,000
Key inclusion criteriaAdult 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.
Key exclusion criteria1. 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
Date of first enrolment01/09/2020
Date of final enrolment01/08/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

John Radcliffe Hospital
Oxford University Hospital NHS Foundation Trust
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

University of Oxford
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone +44 (0)1865 270000
Email ccrg@ndcn.ox.ac.uk
Website https://www.ox.ac.uk
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/08/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planMultiple peer reviewed open access publications.
IPD sharing planIPD 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 26/07/2023 No No

Editorial Notes

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