Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Optimisation of peri-operative cardiovascular management to improve surgical outcome: open randomised controlled multi-centre trial
Acronym
OPTIMISE
Study hypothesis
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
East London and The City Research Ethics Committee, 13/03/2009, ref: 09/H0703/23
Study design
Open randomised controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Available from Contract Research Organisation (CRO): http://www.icnarc.org
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
18/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
734 patients
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
19/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barts and The London School of Medicine and Dentistry
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)
Sponsor details
Joint R&D Office
24 - 26 Walden Street
London
E1 2AN
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Clinician Scientist Award (held by R Pearse)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Intensive Care National Audit and Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24842135
Publication citations
-
Results
Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K, , Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review., JAMA, 2014, 311, 21, 2181-2190, doi: 10.1001/jama.2014.5305.