Optimisation of peri-operative cardiovascular management to improve surgical outcome

ISRCTN	ISRCTN04386758
DOI	https://doi.org/10.1186/ISRCTN04386758
Protocol serial number	N/A
Sponsor	Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)
Funders	National Institute for Health Research (NIHR) (UK) - Clinician Scientist Award (held by R Pearse), Intensive Care National Audit and Research Centre

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

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

Primary study design	Interventional
Study design	Open randomised controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	18/05/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	734
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

United Kingdom
England

Study participating centre

Barts and The London School of Medicine and Dentistry

London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
HRA research summary			28/06/2023	No	No
Other publications	analysis	07/03/2019	31/03/2020	Yes	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

22/10/2019: Publication reference added.
11/03/2019: Publication reference added.