The short and long-term consequences of critical illness on the heart and blood vessels
| ISRCTN | ISRCTN15905609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15905609 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 274165 |
| Protocol serial number | IRAS 274165 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health Research |
- 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
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
Contact information
Scientific
Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-8176-0831 |
|---|---|
| Phone | +44 (0)1865 231456 |
| c3study@ndcn.ox.ac.uk |
Scientific
Kadoorie Centre
John Radlciffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| ORCID ID |
0000-0001-9455-022X |
|---|---|
| Phone | +44 (0)1865 231456 |
| c3study@ndcn.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre reterospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The short and long-term cardiovascular consequences of critical illness: The C3 Study |
| Study acronym | C3 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Measured using electronic healthcare records at 5 years post-discharge from ICU: |
| Key secondary outcome measure(s) |
Hospital re-admission measured using electronic healthcare records at 5 years post-discharge from ICU |
| Completion date | 01/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80000 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 01/08/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Headington
Oxford
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/09/2020: Trial’s existence confirmed by NHS HRA.
