EUCTR2009-009596-35-GB
Active, Not Recruiting
Phase 1
Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome (Optimise Trial) - Optimise
Queen Mary's, University of London0 sites734 target enrollmentApril 16, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post-operative complications in patients who undergo major surgery
- Sponsor
- Queen Mary's, University of London
- Enrollment
- 734
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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