Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review.
OBJECTIVE
Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm.


OBJECTIVE
To evaluate the clinical effectiveness of a perioperative, cardiac output-guided hemodynamic therapy algorithm.


METHODS
OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014.


METHODS
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).


METHODS
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.


RESULTS
Baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, -0.3% to 13.9%]; P = .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, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]).


CONCLUSIONS
In a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates.


BACKGROUND
isrctn.org Identifier: ISRCTN04386758.
Queen Mary University of London, London, England.
Rupert M
RM
Pearse
Intensive Care National Audit and Research Centre, London, England.
David A
DA
Harrison
Queen Mary University of London, London, England.
Neil
N
MacDonald
Critical Care Unit, University of Edinburgh, Edinburgh, Scotland.
Michael A
MA
Gillies
Critical Care Unit, Queen Elizabeth Hospital, King's Lynn, England.
Mark
M
Blunt
University College London, London, England.
Gareth
G
Ackland
Integrative Physiology and Critical Illness Group, University of Southampton, Southampton, England.
Michael P W
MP
Grocott
Queen Mary University of London, London, England.
Aoife
A
Ahern
Intensive Care National Audit and Research Centre, London, England.
Kathryn
K
Griggs
Intensive Care National Audit and Research Centre, London, England.
Rachael
R
Scott
Queen Mary University of London, London, England.
Charles
C
Hinds
Intensive Care National Audit and Research Centre, London, England.
Kathryn
K
Rowan
D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000465:Algorithms; D002302:Cardiac Output; D002318:Cardiovascular Diseases / Q000517:prevention & control; D013505:Digestive System Surgical Procedures / Q000009:adverse effects / Q000401:mortality; D005440:Fluid Therapy; D006439:Hemodynamics; D007902:Length of Stay; D011183:Postoperative Complications / Q000517:prevention & control; D016896:Treatment Outcome