Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/06/2009
Date assigned
24/07/2009
Last edited
04/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.icnarc.org

Contact information

Type

Scientific

Primary contact

Dr Rupert Pearse

ORCID ID

Contact details

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

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 measures

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

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

http://www.bartsandthelondon.nhs.uk/research

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24842135

Publication citations

  1. 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.

Additional files

Editorial Notes