Optimisation of peri-operative cardiovascular management to improve surgical outcome
| ISRCTN | ISRCTN04386758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04386758 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/06/2009
- Registration date
- 24/07/2009
- Last edited
- 31/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rupert Pearse
Scientific
Scientific
Senior Lecturer in Intensive Care Medicine
Barts and The London School of Medicine and Dentistry
Intensive Care Unit
Royal London Hospital
London
E1 1BB
United Kingdom
Study information
| Study design | Open randomised controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Available from Contract Research Organisation (CRO): http://www.icnarc.org |
| Scientific title | Optimisation of peri-operative cardiovascular management to improve surgical outcome: open randomised controlled multi-centre trial |
| Study acronym | OPTIMISE |
| Study objectives | Current hypothesis as of 03/05/2012 To establish whether protocolised administration of intra-venous fluid, combined with low dose dopexamine infusion will reduce the number of patients who experience complications within 30 days following major surgery involving the gastrointestinal tract. Previous hypothesis To establish whether protocolised administration of intra-venous fluid, combined with low dose dopexamine infusion will increase the number of patients who survive to 28 days following major surgery involving the gastrointestinal tract. On 03/05/2012 the following changes were made to the trial record: 1. The overall trial end date was changed from 31/08/2013 to 30/04/2013. 2. The target number of participants has been updated from 3600 to 734. On 10/01/2013 the overall trial end date was changed from 30/04/2013 to 18/05/2013. |
| Ethics approval(s) | East London and The City Research Ethics Committee, 13/03/2009, ref: 09/H0703/23 |
| Health condition(s) or problem(s) studied | Post-operative complications |
| Intervention | Current interventions as of 03/05/2012 The trial intervention period begins at induction of anaesthesia and continues until six hours after surgery is complete (maximum duration 24 hours). For patients in the treatment group, stroke volume will be measured by arterial waveform analysis and 250 ml intra-venous collid fluid challenges will be administered to achieve sustained rise in stroke volume. Patients in the intervention group will also receive a fixed dose intra-venous infusion of dopexamine (0.5 µg/kg/min). Other decisions for intervention group patients will be taken by clinical staff. Control group patients will receive usual clinical care with all decisions taken by clinical staff. Patients will be followed up for 30-day morbidity and mortality and 180-day mortality. Previous interventions Sample size for primary outcome: 3600 patients. However, trial only currently funded to first interim analysis and secondary outcome of the number of patients developing complications within 28 days of surgery (726 patients). The trial intervention period begins at induction of anaesthesia and continues until six hours after surgery is complete (maximum duration 24 hours). For patients in the treatment group, stroke volume will be measured by arterial waveform analysis and 250 ml intra-venous collid fluid challenges will be administered to achieve sustained rise in stroke volume. Patients in the intervention group will also receive a fixed dose intra-venous infusion of dopexamine (0.5 µg/kg/min). Other decisions for intervention group patients will be taken by clinical staff. Control group patients will receive usual clinical care with all decisions taken by clinical staff. Patients will be followed up for 28-day morbidity and mortality and 180-day mortality. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure(s): Difference in the number of patients developing post-operative complications or dying within 30 days following randomisation between study groups. Previous primary outcome measure(s): Difference in 28 days post-mortality between study groups. |
| Secondary outcome measures | Current secondary outcome measure (s) as of 03/05/2012: 1. Difference in the number of patients developing 30-day post-operative mortality between groups 2. Difference in morbidity identified with the Post-Operative Morbidity Survey (POMS) for patients still in hospital on day seven after surgery 3. Difference in the number of patients developing infectious complications within 30 days of surgery 4. Difference in duration of post-operative hospital stay 5. Difference in 30 day critical care free days 6. Difference in 180 day post-operative mortality 7. Difference in cost effectiveness 8. Difference in healthcare costs Previous secondary outcome measure(s): 1. Difference in the number of patients developing post-operative complications within 28 days of surgery between groups 2. Difference in morbidity identified with the Post-Operative Morbidity Survey (POMS) for patients still in hospital on day seven after surgery 3. Difference in the number of patients developing infectious complications within 28 days of surgery 4. Difference in duration of post-operative hospital stay 5. Difference in 28 day critical care free days 6. Difference in 180 day post-operative mortality 7. Difference in cost effectiveness 8. Difference in healthcare costs |
| Overall study start date | 01/09/2009 |
| Completion date | 18/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 734 patients |
| Key inclusion criteria | Adult patients undergoing major abdominal surgery involving the gastrointestinal tract which is expected to take longer than 90 minutes are eligible for recruitment provided they satisfy one of the following additional criteria: 1. Urgent or emergency surgery 2. Acute or chronic renal impairment 3. Diabetes mellitus 4. Aged 65 years and older, either sex 5. Presence of a risk factor for cardiac or respiratory disease |
| Key exclusion criteria | Current exclusion criteria as of 03/05/2012 1. Patients receiving palliative treatment only 2. Acute myocardial ischaemia at time of enrolment 3. Pulmonary oedema at time of enrolment 4. Moderate/severe thromocytopenia (platelet count <50 x 109/l) 5. Patients receiving monoamine oxidase inhibitors (MAOIs) 6. Phaechromocytoma 7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis 8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate 9. Pregnancy 10. Septic shock Previous exclusion criteria 1. Patients receiving palliative treatment only 2. Acute myocardial ischaemia at time of enrolment 3. Pulmonary oedema at time of enrolment 4. Moderate/severe thromocytopenia 5. Patients receiving monoamine oxidase inhibitors (MAOIs) 6. Phaechromocytoma 7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis 8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate 9. Pregnancy |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 19/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barts and The London School of Medicine and Dentistry
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint R&D Office
24 - 26 Walden Street
London
E1 2AN
England
United Kingdom
| Website | http://www.bartsandthelondon.nhs.uk/research |
|---|
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Clinician Scientist Award (held by R Pearse)
No information available
Intensive Care National Audit and Research Centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/06/2014 | Yes | No | |
| Results article | results | 07/03/2019 | 11/03/2019 | Yes | No |
| Results article | substudy results | 01/12/2019 | 22/10/2019 | Yes | No |
| Other publications | analysis | 07/03/2019 | 31/03/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/10/2019: Publication reference added.
11/03/2019: Publication reference added.
