OPTIMISE II

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.

OPTIMISE II is a definitive large trial to evaluate the clinical effectiveness of peri-operative cardiac output guided haemodynamic therapy in high-risk patients aged 65 years and over undergoing major elective gastrointestinal surgery. It will compare this treatment to usual clinical care in 2502 patients across 50 hospitals worldwide.

OPTIMISE-II aims to recruit 2502 patients in 50 hospitals worldwide, but we can only complete the trial on time with a strong contribution from the NHS.

Recruiting hospitals is particularly difficult because so many anaesthetists have strong beliefs that this treatment approach either does or does not work. Whilst we may think we know what the outcome will be, none of us knows for sure. We will struggle to improve the care of our patients unless we support projects which resolve difficult treatment decisions.

The study’s primary objective is to establish whether the use of minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, combined with low dose inotrope infusion, will reduce the number of patients who experience a hospital-acquired infection within 30 days following major elective surgery involving the gastro-intestinal tract.

The secondary objectives will determine whether cardiac output-guided haemodynamic therapy reduces mortality, other forms of postoperative morbidity, improves quality of life and is cost-effective.

• Chief Investigator: Prof Rupert Pearse, Queen Mary University of London
  
• Interested in this trial? Contact us.