The added value of cardiac index and pulse pressure variation monitoring to mean arterial pressure-guided volume therapy in moderate-risk abdominal surgery (COGUIDE): a pragmatic multicentre randomised controlled trial

Abstract

There is disagreement regarding the benefits of goal-directed therapy in moderate-risk abdominal surgery. Therefore, we tested the hypothesis that the addition of non-invasive cardiac index and pulse pressure variation monitoring to mean arterial pressure-based goal-directed therapy would reduce the incidence of postoperative complications in patients having moderate-risk abdominal surgery. In this pragmatic multicentre randomised controlled trial, we randomly allocated 244 patients by envelope drawing in a 1:1 fashion, stratified per centre. All patients had mean arterial pressure, cardiac index and pulse pressure variation measured continuously. In one group, healthcare professionals were blinded to cardiac index and pulse pressure variation values and were asked to guide haemodynamic therapy only based on mean arterial pressure (control group). In the second group, cardiac index and pulse pressure variation values were displayed and kept within target ranges following a pre-defined algorithm (CI-PPV group). The primary endpoint was the incidence of postoperative complications within 30 days. One hundred and seventy-five patients were eligible for final analysis. Overall complication rates were similar (42/94 (44.7%) vs. 38/81 (46.9%) in the control and CI-PPV groups, respectively; p = 0.95). The CI-PPV group had lower mean (SD) pulse pressure variation values (9.5 (2.0)% vs. 11.9 (4.6)%; p = 0.003) and higher mean (SD) cardiac indices (2.76 (0.62) l min .m vs. 2.53 (0.66) l min .m ; p = 0.004) than the control group. In moderate-risk abdominal surgery, we observed no additional value of cardiac index and pulse pressure variation-guided haemodynamic therapy to mean arterial pressure-guided volume therapy with regard to postoperative complications.

Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial)

“…Nonetheless, it is possible that a longer-term follow-up would reveal an effect on postsurgery deaths. 53 The major strength of this study is, unlike recent studies, 59,60 we that have found a significant reduction in moderate-severe postoperative complications in patients who were not at high surgical risk. Identification of the specific patient populations most likely to benefit from GDHT is thus important in future studies.…”

Effects of perioperative goal-directed fluid therapy combined with the application of alpha-1 adrenergic agonists on postoperative outcomes: a systematic review and meta-analysis

“…2 ) and table (Additional file 2 ). A total of 18 studies (58%) [ 25 , 26 , 28 – 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , 45 , 48 – 52 ] were judged to carry a low risk of bias (Table 1 ).

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“…Seventeen trials [ 28 , 29 , 31 – 33 , 35 , 36 , 39 , 41 , 43 , 45 – 51 ] included patients who were less than 65 years old, and 14 trials [ 3 , 9 , 24 – 27 , 30 , 34 , 37 , 38 , 40 , 42 , 44 , 52 ] included patients who were more than 65 years old. As for the type of alpha-1 adrenergic agonists used in studies, 17 studies [ 3 , 25 , 27 – 30 , 34 – 38 , 40 , 44 , 45 , 49 – 52 ] selected norepinephrine, 11 studies [ 24 , 26 , 31 – 33 , 39 , 41 , 42 , 50 , 52 ] considered phenylephrine, 2 studies [ 43 , 46 ] used norepinephrine and phenylephrine, and 1 study [ 9 ] used metaraminol. Additionally, 18 trials [ 3 , 27 – 29 , 31 , 32 , 35 , 37 , 38 , 40 – 45 , 47 , 48 , 52 ] involved abdominal surgery.…”

“…As for the type of alpha-1 adrenergic agonists used in studies, 17 studies [ 3 , 25 , 27 – 30 , 34 – 38 , 40 , 44 , 45 , 49 – 52 ] selected norepinephrine, 11 studies [ 24 , 26 , 31 – 33 , 39 , 41 , 42 , 50 , 52 ] considered phenylephrine, 2 studies [ 43 , 46 ] used norepinephrine and phenylephrine, and 1 study [ 9 ] used metaraminol. Additionally, 18 trials [ 3 , 27 – 29 , 31 , 32 , 35 , 37 , 38 , 40 – 45 , 47 , 48 , 52 ] involved abdominal surgery. Four trials [ 34 , 46 , 50 , 51 ] were related to thoracic surgery.…”

What should we do when traditional research fails?

“…However, definitive evidence of benefit has remained elusive, perhaps with the exception of elective high‐risk surgery. The paper by Stens et al in this issue of Anaesthesia adds to the growing number of clinical trials that seem to fail to demonstrate that GDFT has a place in clinical practice . Their study investigated the added value of cardiac index and pulse pressure variation (PPV) monitoring to mean arterial pressure (MAP)‐guided volume therapy in moderate‐risk abdominal surgery.…”