Abdominal Surgery Clinical Trial
Official title:
Restrictive Versus Liberal Fluid Therapy in Major Abdominal Surgery
The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or
crystalloid) for patients undergoing major surgery are based on rationales that are not
supported by strong evidence. Practices vary substantially, guidelines are vague, small
trials and meta-analyses are contradictory. The strongest and most consistent evidence, and
biological plausibility because of tissue edema, supports a restrictive fluid strategy. But
other evidence supports goal-directed therapy, requiring additional IV fluid. There is no
good evidence that use and choice of colloids improves outcome. RELIEF will study the effects
of fluid restriction, and the possible effect-modification of goal-directed therapy and
colloids. The first will be randomly assigned; the latter will be measured covariates
dictated by local practices and beliefs.
Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery
leads to reduced complications and improved disability-free survival when compared with a
liberal fluid regimen.
Secondary hypothesis: The effects of fluid restriction are similar whether or not
goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive
fluid regimen will reduce a composite of 30-day septic complications and mortality.
The investigators have completed a pilot study of 82 subjects to test the feasibility of the
trial (2011), and are currently doing a cost-effectiveness substudy (2012-13)
1. AIM OF THE TRIAL To investigate the effectiveness of fluid restriction (vs. liberal), and
the possible effect-modification of goal-directed therapy (eg. oesophageal Doppler,
Flotrac®). The first will be randomly assigned; the latter will be measured covariates
according to local practices and beliefs.
The optimal fluid regimen and haemodynamic (or other) targets for patients undergoing major
surgery are based on rationales that are not supported by strong evidence. Practices vary
substantially; guidelines are vague, small trials and meta-analyses are contradictory. The
strongest and most consistent evidence, and biological plausability regarding tissue oedema,
supports a restrictive fluid strategy. There is less (and more contradictory) evidence
supporting goal-directed therapy using a flow-directed device and/or dopexamine, and use and
choice of colloids. A large, definitive clinical trial evaluating perioperative fluid
replacement in major surgery is required.
Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery
leads to reduced complications and improved disability-free survival when compared with a
liberal fluid regimen.
Secondary hypotheses: The effects of fluid restriction are similar whether or not
goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive
fluid regimen will reduce a composite of 30-day septic complications and mortality.
;
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