OPTIMISE II
Research type
Research Study
Full title
Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) Trial: Open, multi-centre, randomised controlled trial of cardiac output-guided fluid therapy with low dose inotrope infusion compared to usual care in patients undergoing major elective gastrointestinal surgery.
IRAS ID
209688
Contact name
Ann Thomson
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
We aim to resolve a long standing controversy in the care of patients undergoing major surgery by evaluating the safety and effectiveness of a technology called cardiac output monitoring in guiding the dose and timing of intra-venous fluid and powerful drugs which increase heart function.
Around 40,000 NHS patients aged 65 years and over undergo major planned gut surgery each year. After surgery, more than 12,000 patients develop hospital acquired infection, and 3,600 die within 180 days. Patients who survive complications to leave hospital commonly suffer a loss of mobility, independence and reduced long-term survival. Hospital acquired infections in this patient group cost the NHS more than £80 million each year. We know that complications after surgery are more likely if patients receive too much or too little intra-venous fluid (administered into a vein). The use of small doses of drugs that increase heart function (inotropic drugs) is also important. Currently, the type and dose of these drug treatments is decided by a doctor based on subjective assessment of the patient. Advanced cardiac monitoring technologies may provide a more reliable guide to the use of these treatments. However, only one third of eligible patients currently receive this treatment because many doctors are concerned this approach is more aggressive and may therefore harm some patients by causing small heart attacks. Only a large clinical trial can resolve this uncertainty, allowing us to provide this treatment to all eligible patients if beneficial, or withdraw it from use if ineffective or harmful.
We aim to confirm the effect of cardiac output guided therapy on the number of patients who develop hospital acquired infection within 30 days after major planned gastrointestinal surgery. We propose an international multi-centre clinical trial in 2502 patients aged 65 and over recruited over a three year period.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/2067
Date of REC Opinion
9 Dec 2016
REC opinion
Favourable Opinion