A review and analysis of treatments for irregular heart rhythm
| ISRCTN | ISRCTN13252515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13252515 |
- Submission date
- 04/02/2019
- Registration date
- 11/02/2019
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Current plain English summary as of 18/10/2019:
Background and study aims
Atrial fibrillation is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart’s ability to pump blood around the body efficiently. It also increases the risk of blood clots forming inside the heart. These clots may then be pumped out of the heart, through the blood vessels, to other parts of the body. This causes strokes if they spread to the brain.
Atrial fibrillation is a common problem in patients outside intensive care units (ICUs). Good, evidence-based, guidelines exist to help doctors treat people who develop this condition.
Around 10% of people treated on an ICU develop atrial fibrillation as a complication of their severe underlying illness. This additional problem makes them more unstable so they stay longer in the ICU and are more likely to die. Atrial fibrillation therefore needs prompt and effective treatment to prevent further harm.
Treatments for atrial fibrillation that work in people who are otherwise well may not work in people who are already very ill before their heart changes rhythm. This means that guidelines for treating atrial fibrillation outside ICU are not helpful for patients treated on an ICU. There is uncertainty about the best treatment, and practices differ between countries and between different ICUs in the same country.
People who have atrial fibrillation outside an ICU are often given medications such as warfarin (commonly referred to as a “blood-thinner”) to reduce their risk of stroke. However these medications can cause bleeding. Risk scoring systems are used to help doctors balance the risk of bleeding against the risk of stroke but these scoring systems may not work for patients admitted to ICUs. This is because their risk of bleeding is higher and their risk of stroke is not well understood.
Our research will bring together the best evidence on which to base improved guidelines for the treatment of patients who develop atrial fibrillation on an ICU. We will start with a review of all published research and expert opinions. This is called a scoping review. It will also suggest the best areas for future research.
Who can participate?
With permission, we will use databases of medical records of patients treated on ICUs to investigate the benefits and harms of existing treatments for atrial fibrillation. Using existing data is a cost-efficient way to work out which treatments need more detailed investigation.
We will use two databases, PICRAM and MIMIC-III, to see which treatments appear to work best for atrial fibrillation. PICRAM is a large detailed research database of patients admitted to three ICUs in the UK. It includes information about 13,000 patients. MIMIC-III holds similar data on 52,000 patients from the ICUs of one large US hospital. Many treatments are different in the two countries, including treatment for atrial fibrillation.
The NIHR HIC critical care database holds some of the clinical details on 40,000 patients from five UK ICUs. We will use this to check some of our findings.
What does the study involve?
To understand how we could improve outcomes for patients who develop atrial fibrillation on an ICU by thinning their blood, we need to know how frequently strokes occur, both in hospital and after they go home. We will use the RISK-II database of over 900,000 patients treated on 200 ICUs in England to estimate how many patients suffered a stroke in hospital and after discharge.
What are the possible benefits and risks of participating?
Not applicable
Where is the study run from?
University of Oxford, Kadoorie Centre for Critical Care Research & Education, Level 3 John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK
When is the study starting and how long is it expected to run for?
February 2019 to November 2020
Who is funding the study?
National Institute for Health Research Health Technology Assessment
Who is the main contact?
Rachel Henning, ccrg@ndcn.ox.ac.uk
Previous plain English summary:
Background and study aims
Atrial fibrillation is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart’s ability to pump blood around the body efficiently. It also increases the risk of blood clots forming inside the heart. These clots may then be pumped out of the heart, through the blood vessels, to other parts of the body. This causes strokes if they spread to the brain.
Atrial fibrillation is a common problem in patients outside intensive care units (ICUs). Good, evidence-based, guidelines exist to help doctors treat people who develop this condition.
Around 10% of people treated on an ICU develop atrial fibrillation as a complication of their severe underlying illness. This additional problem makes them more unstable so they stay longer in the ICU and are more likely to die. Atrial fibrillation therefore needs prompt and effective treatment to prevent further harm.
Treatments for atrial fibrillation that work in people who are otherwise well may not work in people who are already very ill before their heart changes rhythm. This means that guidelines for treating atrial fibrillation outside ICU are not helpful for patients treated on an ICU. There is uncertainty about the best treatment, and practices differ between countries and between different ICUs in the same country.
People who have atrial fibrillation outside an ICU are often given medications such as warfarin (commonly referred to as a “blood-thinner”) to reduce their risk of stroke. However these medications can cause bleeding. Risk scoring systems are used to help doctors balance the risk of bleeding against the risk of stroke but these scoring systems may not work for patients admitted to ICUs. This is because their risk of bleeding is higher and their risk of stroke is not well understood.
Our research will bring together the best evidence on which to base improved guidelines for the treatment of patients who develop atrial fibrillation on an ICU. We will start with a review of all published research and expert opinions. This is called a scoping review. It will also suggest the best areas for future research.
Who can participate?
With permission, we will use databases of medical records of patients treated on ICUs to investigate the benefits and harms of existing treatments for atrial fibrillation. Using existing data is a cost-efficient way to work out which treatments need more detailed investigation.
We will use two databases, PICRAM and MIMIC-III, to see which treatments appear to work best for atrial fibrillation. PICRAM is a large detailed research database of patients admitted to three ICUs in the UK. It includes information about 18,000 patients. MIMIC-III holds similar data on 52,000 patients from the ICUs of one large US hospital. Many treatments are different in the two countries, including treatment for atrial fibrillation.
The NIHR HIC critical care database holds some of the clinical details on 40,000 patients from five UK ICUs. We will use this to check some of our findings.
What does the study involve?
To understand how we could improve outcomes for patients who develop atrial fibrillation on an ICU by thinning their blood, we need to know how frequently strokes occur, both in hospital and after they go home. We will use the RISK-II database of over 900,000 patients treated on 200 ICUs in England to estimate how many patients suffered a stroke in hospital and after discharge.
What are the possible benefits and risks of participating?
Not applicable
Where is the study run from?
University of Oxford, Kadoorie Centre for Critical Care Research & Education, Level 3 John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK
When is the study starting and how long is it expected to run for?
February 2019 to August 2020
Who is funding the study?
National Institute for Health Research Health Technology Assessment
Who is the main contact?
Julie Darbyshire, julie.darbyshire@ndcn.ox.ac.uk
Contact information
Public
Kadoorie Centre for Critical Care Research and Education
Level 3, John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223101 |
|---|---|
| ccrg@ndcn.ox.ac.uk |
Scientific
University of Oxford Critical Care Research Group
Nuffield Department for Clinical Neurosciences
Kadoorie Centre for Critical Care Research & Education
Level 3, John Radcliffe Hospital
Headley Way, Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223101 |
|---|---|
| ccrg@ndcn.ox.ac.uk |
Study information
| Study design | Two phase project. Phase 1: scoping review; Phase 2: retrospective database analysis |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Critical Care Atrial Fibrillation Evaluation: a scoping review and data base analysis |
| Study acronym | CAFE |
| Study objectives | Scoping review 1. To evaluate the evidence for the effectiveness and safety of: a. pharmacological and non-pharmacological (electrical, electrolyte, fluid) New-onset atrial fibrillation (NOAF) treatments; and b. acute anticoagulation 2. To provide guidance for the database analysis on: a. NOAF definitions used in patients on an ICU; b. patient subgroups who develop NOAF on an ICU; and c. inclusion/exclusion of specific treatments and potential confounders. 3. To determine barriers to future research. Database analysis 1. To compare the use and effectiveness of pharmacological and non-pharmacological NOAF treatments with respect to heart rate and rhythm control. 2. To assess anticoagulation use, effect on thromboembolic complications and safety. 3. To determine the incidence of short and long-term complications of NOAF and identified treatments. |
| Ethics approval(s) | Approved 17/07/2019, Committee on Clinical Investigations (Beth Israel Deaconess Medical Center, 330 Brookline Ave., Boston, MA 02215, USA; +1 617-975-8511, alisbon@bidmc.harvard.edu), ref: 2001P001699 |
| Health condition(s) or problem(s) studied | Patients who experience new onset atrial fibrillation (NOAF) during their admission for intensive care |
| Intervention | None - retrospective data analysis & review of literature only |
| Intervention type | Other |
| Primary outcome measure | To evaluate the evidence for the effectiveness and safety of treatment for new onset atrial fibrillation (NOAF) in the intensive care unit |
| Secondary outcome measures | 1. To assess anticoagulation use and their effect on thromboembolic complications and safety 2. To determine the incidence of short and long-term complications of NOAF and identified treatments 3. To determine barriers to future research in the field |
| Overall study start date | 30/11/2017 |
| Completion date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | ~1,000,000 across all datasets |
| Total final enrolment | 759964 |
| Key inclusion criteria | To be included in the retrospective data analysis phase of the project patients must have been admitted to one of the intensive care units included in the PICRAM & MIMIC-III datasets |
| Key exclusion criteria | 1. Patients with known prior AF 2. Patients (and studies for the scoping review) with evidence of NOAF outside of the intensive care unit |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
Study participating centres
Level 3 John Radcliffe Hospital
Headley Way, Headington
Oxford
OX3 9DU
United Kingdom
24 High Holborn
London
WC1V 6AZ
United Kingdom
University of York
York
YO10 5DD
United Kingdom
Sponsor information
University/education
Joint Research Office
1st Floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 289809 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/ctrg |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
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 date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author (ccrg@ndcn.ox.ac.uk) on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Literature review | 21/07/2021 | 02/09/2021 | Yes | No |
| Results article | Effectiveness of treatments | 16/11/2021 | 13/01/2022 | Yes | No |
| Results article | Epidemiology and outcomes | 06/07/2022 | 08/07/2022 | Yes | No |
| Protocol file | version 1.1 | 20/02/2019 | 18/08/2022 | No | No |
| Results article | 01/11/2021 | 06/03/2024 | Yes | No |
Additional files
Editorial Notes
06/03/2024: Publication reference added.
18/08/2022: Protocol file uploaded.
08/07/2022: Publication reference added.
13/01/2022: Publication reference added.
02/09/2021: Publication reference added.
05/02/2021: The final enrolment number has been added.
22/01/2021: Contact details updated.
11/12/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/08/2020 to 30/11/2020.
2. The intention to publish date was changed from 31/12/2020 to 31/03/2021.
3. The trial website was added.
3. The plain English summary was updated to reflect these changes.
06/07/2020: The overall trial end date was changed from 31/07/2019 to 01/08/2020.
18/10/2019: The plain English summary has been updated.
15/02/2019: Internal review.
