Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome (Optimise Trial) - Optimise
- Conditions
- Post-operative complications in patients who undergo major surgery
- Registration Number
- EUCTR2009-009596-35-GB
- Lead Sponsor
- Queen Mary's, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 734
Adult patients undergoing major abdominal surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes will be eligible for recruitment provided they satisfy one of the following criteria:
Age 65 years and over
Or…
Age 50-64 plus, one or more of:
-non-elective surgery;
-acute or chronic renal impairment (serum creatinine >130 µmol/l)
-diabetes mellitus
-presence of a risk factor for cardiac or respiratory disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Refusal of consent
•Patients receiving palliative treatment only (likely to die within 30 days)
•Acute myocardial ischaemia (within 30 days prior to randomisation)
•Acute pulmonary oedema (within 7 days prior to randomisation)
•Septic shock at time of enrolment
•Thrombocytopenia (platelet count <50 x 109 l-1)
•Patients who are receiving monoamine oxidase inhibitors (MAOIs)
•Phaeochromocytoma
•Severe Left ventricular outlet obstruction eg due to hypertrophic obstructive cardiomyopathy or severe aortic stenosis
•Known hypersensitivity to dopexamine hydrochloride or disodium edentate
•Pregnancy at time of enrolment
•Failure to meet the inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method