A clinical trial of blood flow optimisation for patients who have emergency bowel surgery
| ISRCTN | ISRCTN14729158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14729158 |
| IRAS number | 214459 |
| Secondary identifying numbers | CRI0336; HTA 15/80/54 |
- Submission date
- 10/04/2017
- Registration date
- 02/05/2017
- Last edited
- 16/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Emergency bowel surgery (laparotomy) is a major procedure which can lead to reduced blood flow to vital organs. This can lead to complications after surgery. Fluids are given into the bloodstream (intravenous) to improve blood flow. Giving the right amount of this intravenous fluid at the right time is important for recovery after surgery, but is hard to gauge accurately. Doctors normally use signs such as heart rate and blood pressure to guide them, but these can be unreliable. Previous research has shown that a treatment used during surgery and shortly afterwards may improve the amount of oxygen delivered to the body’s tissues and reduce the number of patients who develop complications after surgery. This treatment involves using a heart monitor (cardiac output monitor) to help clinical teams decide the amount and timing of intravenous fluid to give to patients. There is some evidence from smaller studies that this treatment is beneficial, but this needs to be confirmed in a much larger study. The aim of this study is to find out whether the use of cardiac output monitoring to guide the use of intravenous fluid increases the number of days spent alive and out of hospital within 90 days of randomisation compared with usual care.
Who can participate?
Patients aged 50 and over undergoing emergency laparotomy
What does the study involve?
During and after surgery, participants are randomly allocated to receive one of the treatments, either the study treatment or usual care. Participants' experiences are the same regardless of which treatment they receive, and they probably won’t be able to tell which one they are getting. Both treatments begin at the start of surgery and finish six hours after it has ended. The two treatments involve slightly different ways of deciding the amount of intravenous fluid participants receive. If they receive usual care their doctor uses measurements such as heart rate and blood pressure to guide this. If they receive the new study treatment their clinical team also measures the amount of blood their heart pumps each minute using an extra monitor. These extra measurements help the doctor to decide how much intravenous fluid they give. After the treatment is over, care continues as normal and there is no need to contact the participants further. Routinely collected information from medical notes and NHS databases is used to follow-up participants' recovery after surgery.
What are the possible benefits and risks of participating?
Previous research suggests that the treatment is safe and should benefit most patients. Participants are closely monitored throughout the study and, if necessary, their clinical team makes adjustments to their treatment to make sure they are safe.
Where is the study run from?
50 hospitals in the UK, led by Southampton General Hospital
When is the study starting and how long is it expected to run for?
May 2017 to December 2025
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Zoe Clark, admin@floela.org
Contact information
Public
Research and Development
Southampton Centre for Biomedical Research
University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8120 1863 |
|---|---|
| zoe.clark@uhs.nhs.uk |
Scientific
University Hospital Southampton
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-5048-1784 |
|---|---|
| admin@floela.org |
Study information
| Study design | Randomized controlled trial with open study group allocation and internal pilot study, supported by ongoing data collection from the National Emergency Laparotomy Audit (NELA) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN14729158_PIS_V6.0_01Jul20.pdf |
| Scientific title | FLuid Optimisation in Emergency LAparotomy (FLO-ELA): an open, multi-centre, randomised controlled trial of cardiac output-guided haemodynamic therapy compared to usual care in patients undergoing emergency bowel surgery |
| Study acronym | FLO-ELA |
| Study hypothesis | To establish whether the use of minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid (goal-directed haemodynamic therapy, GDHT), for patients aged 50 and over undergoing emergency laparotomy will reduce mortality within 90 days of randomisation, when compared with usual care. |
| Ethics approval(s) | London - Bromley Research Ethics Committee, 28/03/2017, ref: 17/LO/0334 |
| Condition | Surgery - emergency laparotomy |
| Intervention | The trial treatment period will commence at the start of general anaesthesia and continue for six hours after the completion of surgery. Eligible patients will be randomised to receive either cardiac-output guided haemodynamic therapy (intervention group), or usual care (control group). Perioperative management for all patients during the trial treatment period will be in accordance with recommended guidance. Intervention: Treatment algorithm guided by cardiac output monitoring to determine dose and timing of intravenous fluid. Clinicians may choose from a range of cardiac output monitors in established use which have been shown to track changes in cardiac stroke volume accurately. 250ml aliquots of crystalloid or colloid solution will be administered according to the algorithm to achieve and maintain an optimal value of stroke volume. This intervention supplements but does not replace the monitoring used for conventional clinical assessments. The protocol allows the treating clinician to adjust the volume and type of fluid administered, e.g. if there is concern about persistent hypovolaemia or fluid overload. Control: Usual care, with intravenous fluid given according to conventional clinical assessment without the use of cardiac output monitoring or algorithm. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 23/12/2021: Days Alive and Out of Hospital within 90 days of randomisation (DAOH-90) _____ Previous primary outcome measure: Mortality within 90 days of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents) |
| Secondary outcome measures | Current secondary outcome measures as of 23/12/2021: Mortality within 90 days of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents) Process outcomes: 1. Duration of hospital stay, from data entered into the National Emergency Laparotomy Audit (NELA) by teams in each participating hospital 2. Duration of stay in a critical care bed within the primary hospital admission, from data entered into NELA by teams in each participating hospital 3. Hospital readmission as an inpatient (overnight stay) within 90 days from randomisation, using data from NHS Digital/Hospital Episode Statistics (or equivalents) Health economic endpoints: 1. Mean cost of implementing the intervention and control treatments 2. Mean cost of secondary care resource use within 90 days from randomisation 3. Quality-adjusted life year gain at 90 days from randomisation using EQ-5D-3L-derived utility scores at baseline and 90 day follow-up (estimated from preceding EPOCH trial data – no EQ-5D-3L data collection will be required within the FLO-ELA trial) _____ Previous secondary outcome measures: Mortality within one year of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents) Process outcomes: 1. Duration of hospital stay, from data entered into the National Emergency Laparotomy Audit (NELA) by teams in each participating hospital 2. Duration of stay in a critical care bed within the primary hospital admission, from data entered into NELA by teams in each participating hospital 3. Hospital readmission as an inpatient (overnight stay) within 90 days from randomisation, using data from NHS Digital/Hospital Episode Statistics (or equivalents) Health economic endpoints: 1. Mean cost of implementing the intervention and control treatments 2. Mean cost of secondary care resource use within 90 days from randomisation 3. Quality-adjusted life year gain at 90 days from randomisation using EQ-5D-3L-derived utility scores at baseline and 90 day follow-up (estimated from preceding EPOCH trial data – no EQ-5D-3L data collection will be required within the FLO-ELA trial) |
| Overall study start date | 01/05/2017 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 3138 |
| Total final enrolment | 3138 |
| Participant inclusion criteria | 1. Age 50 years and over 2. Scheduled to undergo a surgical procedure which fulfils the criteria for entry into the National Emergency Laparotomy Audit (NELA), i.e. an expedited, urgent or emergency abdominal procedure on the gastrointestinal tract within the audit scope, including: 2.1. Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction 2.2. Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis) 2.3. Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair) 2.4. Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. ‘burst abdomen’) or after patients underwent non-elective gastro-intestinal surgery 3. Patient has an NHS number The term “emergency” laparotomy is defined in line with NELA and the National Confidential Enquiry into PeriOperative Deaths (NCEPOD) 2004, to encompass the following categories: “immediate” surgery (required within two hours of the decision to operate), “urgent” surgery (required within 2-18 hours of the decision to operate) and “expedited” surgery (required within 18-24 hours of the decision to operate) |
| Participant exclusion criteria | 1. Refusal of patient consent 2. Clinician refusal 3. Previous enrolment in the FLO-ELA trial 4. Previous inclusion in NELA within the current hospital admission 5. Current participation in another clinical trial of a treatment with a similar biological mechanism 6. Scheduled abdominal procedure outside the scope of NELA, including: elective procedures, uncomplicated appendicectomy or cholecystectomy, non-elective hernia repair without bowel resection, vascular surgery, including abdominal aortic aneurysm repair, Caesarean section, obstetric laparotomies or gynaecological laparotomy, or laparotomy/laparoscopy for pathology caused by trauma |
| Recruitment start date | 01/07/2017 |
| Recruitment end date | 28/11/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
NW3 2QG
United Kingdom
ME7 5NY
United Kingdom
HG2 7SX
United Kingdom
CV34 5BW
United Kingdom
NG17 4JL
United Kingdom
TQ2 7AA
United Kingdom
TN37 7PT
United Kingdom
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Watford
WD18 0HB
United Kingdom
London
SE1 7EH
United Kingdom
Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Sunderland
SR4 7TP
United Kingdom
London
SE13 6LH
United Kingdom
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom
Burton-on-trent
DE13 0RB
United Kingdom
Croydon
CR7 7YE
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Derby
DE22 3NE
United Kingdom
Kew
Southport
PR8 6NJ
United Kingdom
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom
Bath
BA1 3NG
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
London
SE5 9RS
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Romford
RM7 0AG
United Kingdom
Worcester
WR5 1DD
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
London
E11 1NR
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Sponsor information
Hospital/treatment centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 23/12/2021: 1. Final Report to funder - January 2024 2. Planned publication in a high impact peer reviewed journal - summer 2024 3. Conferences and meetings - 2024 - ongoing _____ Previous publication and dissemination plan: 1. Final Report to funder - March 2022 2. Planned publication in a high impact peer reviewed journal - summer 2022 3. Conferences and meetings - 2022 - ongoing |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from admin@floela.org. Any data sharing requests will be subject to the Pragmatic Clinical Trials Unit data sharing policy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V6.0 | 01/07/2020 | 21/07/2020 | No | Yes |
| Protocol file | version V2.0 | 29/04/2020 | 21/07/2020 | No | No |
| Protocol file | version 3.0 | 22/09/2021 | 23/03/2022 | No | No |
| Protocol file | version 4.0 | 27/04/2022 | 24/05/2022 | No | No |
| Protocol article | 06/05/2023 | 09/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14729158_PIS_V6.0_01Jul20.pdf
- Uploaded 21/07/2020
- ISRCTN14729158_PROTOCOL_V2.0_29Apr20.pdf
- Uploaded 21/07/2020
- ISRCTN14729158 Protocol v3.0 22Sept2021.pdf
- ISRCTN14729158 protocol v4.0 27Apr22.pdf
Editorial Notes
16/01/2025: Contact details updated.
15/01/2025: The recruitment end date was changed from 31/12/2024 to 28/11/2024. Total final enrolment added.
11/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 31/12/2024.
2. The overall end date was changed from 31/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 31/01/2025 to 31/01/2026.
4. The contacts were updated.
5. The plain English summary was updated to reflect these changes.
09/05/2023: Publication reference added.
01/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2022 to 31/12/2023.
2. The overall end date was changed from 31/01/2024 to 31/12/2024.
3. The intention to publish date was changed from 31/07/2024 to 31/01/2025.
4. The plain English summary was updated to reflect these changes.
24/05/2022: The following changes were made to the trial record:
1. Uploaded protocol v4.0 (not peer-reviewed) as an additional file.
2. A public contact was added.
3. The recruitment end date was changed from 01/07/2022 to 01/11/2022.
4. The trial participating centres King's Mill, Watford General, St Thomas, St James University Hospital, Queen Elizabeth Birmingham, Royal London, Royal Victoria Infirmary, Sunderland Royal, University Hospital Lewisham, Aintree University Hospital, Queens Hospital Burton, Croydon University Hospital, Royal Bournemouth, Royal Derby, Southport District General, University Hospital North Durham, Royal United Bath, Southmead, Denmark Hill, Northwick Park, William Harvey, Norfolk & Norwich University Hospital, Queens Hospital Romford, Worcestershire Royal, Royal Shrewsbury, University Hospital Wales, Manchester Royal Infirmary, Whipps Cross, Victoria Hospital were added.
5. The trial participating centres City Hospital- Sandwell, Glan Clwyd Hospital, Royal Gwent Hospital, Great Western Hospital, Luton & Dunstable Hospital, Musgrove Park Hospital, Birmingham Heartlands Hospital, Royal Preston Hospital, Basingstoke Hospital, Wye Valley- Hereford Hospital, Northampton General Hospital, Queen Alexandra Hospital- Portsmouth , Tameside Hospital, James Paget Hospital, Lister Hospital, Chelsea & Westminster Hospital, East Surrey Hospital, Amersham Hospital, Leighton Hospital, Royal Berkshire Hospital, Basildon Hospital were removed.
23/03/2022: Uploaded protocol v3.0 (not peer-reviewed) as an additional file.
30/12/2021: The following changes have been made:
1. The public contact has been changed.
2. The IRAS number has been added.
23/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2023 to 31/01/2024.
2. The primary outcome measure was changed
3. The secondary outcome measures were changed
4. The target number of participants was changed from 7646 to 3138.
5. The publication and dissemination plan was changed.
6. The intention to publish date was changed from 31/01/2024 to 31/07/2024.
7. The plain English summary was updated to reflect these changes.
06/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2021 to 01/07/2022.
2. The overall trial end date has been changed from 31/01/2022 to 01/07/2023.
3. The intention to publish date has been changed from 01/06/2022 to 31/01/2024.
25/11/2020: The recruitment end date was changed from 01/01/2021 to 30/04/2021.
23/09/2020: Recruitment to this study is no longer paused.
21/07/2020: Uploaded protocol Version 2.0, 29 April 2020 (not peer reviewed). The participant information sheet has been uploaded.
20/05/2020: The recruitment end date was changed from 01/07/2020 to 01/01/2021.
20/03/2020: Due to current public health guidance, recruitment for this study has been paused.
