Abstract
BackgroundPerioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications.MethodsA randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI ≥ 2.5 L/min/m2 using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017.ResultsA total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, − 7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59–1.23; p = 0.4; p for heterogeneity = 0.7; I2 = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71–1.08; p = 0.2; p for heterogeneity = 0.07; I2 = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) – 1.6; 95% CI – 2.75 to − 0.46; p = 0.006; p for heterogeneity = 0.002; I2 = 74%).ConclusionsCI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery.Trial registrationwww.clinicaltrials.gov, NCT01946269. Registered on 16 September 2013.
Highlights
Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality
cardiac index (CI)-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery
Intervention period In the first 8 h after intensive care unit (ICU) admission, there was no difference between groups in the volume of administered fluids (1195 ± 719 ml GDHT group vs 1290 ± 609 ml usual care group, p = 0.4) and in the red blood cell (RBC) transfusion rate (3.1% GDHT group vs 0% usual care group, p = 0.5)
Summary
Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. Even if some studies suggested that GDHT in high-risk patients undergoing surgery was associated with a significant reduction in morbidity and mortality [4,5,6], recent evidence suggests that the benefits are less than previously hypothesized because of the potential harm of fluid overload, drugs side effects and invasive monitoring [7, 8]. In most studies GDHT was investigated during surgery and extending for the first 6–12 h after intensive care unit (ICU) admission It is unclear whether the potential benefits of GDHT are present when GDHT is used during the whole perioperative period or if GDHT use only in the postoperative ICU setting might result in clinical benefits or even in harmful interventions
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