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Effect of a Perioperative, Cardiac Output–Guided Hemodynamic Therapy Algorithm on Outcomes Following Major Gastrointestinal Surgery: A Randomized Clinical Trial and Systematic Review
Study Questions:
How clinically effective is a perioperative, cardiac output–guided hemodynamic therapy algorithm?
Methods:
The authors reported the results of the OPTIMISE trial. This was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients ages ≥50 years undergoing major gastrointestinal surgery at 17 hospitals in the United Kingdom. Patients were randomly assigned to a cardiac output–guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n = 368), or to usual care (n = 366). The primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care–free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay. The authors also performed an updated systematic review and meta-analysis including randomized trials published from 1966 to February 2014.
Results:
There was no difference in the primary endpoint (36.6% vs. 43.4% with usual care; relative risk [RR], 0.84; 95% confidence interval [CI], 0.71-1.01; p = 0.07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggested that the intervention is associated with fewer complications (RR, 0.77; 95% CI, 0.71-0.83) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality and mortality at longest follow-up (RR, 0.86; 95% CI, 0.74-1.00).
Conclusions:
There was no difference in the perioperative complication rate with the use of a cardiac output–guided hemodynamic therapy algorithm compared with usual care. Inclusion of these data in an updated meta-analysis suggested that intervention was associated with a reduction in complication rates with no difference in mortality.
Perspective:
This study failed to show a benefit of using cardiac output–guided perioperative therapy among patients undergoing major gastrointestinal surgery. The results of the meta-analysis should be considered hypothesis generating since the different studies used slightly different endpoints and no survival benefit was detected. It is possible that the results would have been different if a different method of measuring cardiac output had been used. Overall, there appears to be a marginal benefit of using this approach. Based on these data, hemodynamic guidance for perioperative management cannot be routinely recommended and is best reserved for select high-risk patients.
Keywords: Risk, United Kingdom, Follow-Up Studies, Morbidity, Digestive System Surgical Procedures, Cardiac Output, Dopamine, Critical Care, Hemodynamics, Length of Stay
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