OPTIMISE Trial

• Research type

  Research Study

• Full title

  Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome

• IRAS ID

  3516

• Contact name

  Rupert Pearse

• Sponsor organisation

  Queen Mary's University of London

• Eudract number

  2009-009596-35

• ISRCTN Number

  pending

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  At least 170,000 high-risk surgical procedures are performed in the UK each year with complication rates of over 50%. A number of small single centre studies have suggested complication rates may be reduced by a different approach to intra-venouflud therapy coupled with the use of a drug to improve the amount of blood the heart pumps around the body. This treatment has been termed 'haemodynamic optimisation' or 'goal directed haemodynamic therapy' and is essentially a protocolised method of determining the optimal dose of treatments already routinely used in the peri-operative period. Although the small trials of this treatment are very encouraging, it is important to demonstrate that this treatment remains effective in a large trial in several hospitals. This will show that the findings of smaller trials are widely generalisable to the National Health Service and that the protocol is practical enough for routine use outside centres of expertise in this field.The aim of this study is to assess the effect of a peri-operative haemodynamic optimisation protocol on complication rates in high-risk patients undergoing major gastro-intestinal surgery. Patients will be randomised to usual clinical care or a treatment algorithm for intra-venouflud and low-dose inotropic therapy during surgery and for the first six hours after surgery. The study commenced in June 2010 and is expected to end in late 2012 or early 2013Although the small trials of this treatment are very encouraging, it is important to demonstrate that this treatment remains effective in a large trial in several hospitals. This will show that the findings of smaller trials are widely generalisable to the National Health Service and that the protocol is practical enough for routine use outside centres of expertise in this field.The aim of this study is to assess the effect of a peri-operative haemodynamic optimisation protocol on complication rates following after major gastro-intestinal surgery when compared to conventional medical care.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/23

• Date of REC Opinion

  13 Mar 2009

• REC opinion

  Favourable Opinion