Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894).

BACKGROUND: During a previous study on intraoperative goal-directed haemodynamic treatment (GDHT) in elderly patients, cardiac performance did not improve as anticipated (ClinicalTrials.gov NCT01141894). We hypothesized that in this group, responsiveness to interventions could be predicted by individual patient characteristics. METHODS: Data for the present study were collected during a previously performed, single-centre, open, randomized, and controlled parallel-group superiority trial in patients aged ≥70 yr undergoing hip-fracture surgery. Haemodynamic parameters were collected by the LiDCOplus™ monitor. The GDHT group received oxygen delivery-guided fluid challenges and dobutamine infusion. Management in the routine fluid treatment group was clinician guided without access to LiDCOplus™ readings. In the GDHT group, independent predictors were assessed by multiple logistic regression analyses of two outcomes: first fluid challenge response (defined as increase of stroke volume by ≥10%); and overall intervention response (maintenance of oxygen delivery at the end of surgery). RESULTS: Data from 72 routine fluid treatment and 70 GDHT patients were analysed. Clinician-guided pre-anaesthesia fluid loading increased the stroke volume in 14% of patients, and 17% of patients increased or maintained oxygen delivery at the end of surgery. The GDHT-guided first and subsequent fluid challenges were associated with increased stroke volume in 39 and 9% of patients, respectively, and increased or maintained oxygen delivery was present in 47% of patients at the end of surgery. In the GDHT group, a baseline stroke volume index (<28 ml m(-2)) was an independent predictor of first fluid challenge response, and a baseline oxygen delivery index (<330 ml min(-1) m(-2)) was a predictor of maintained or increased oxygen delivery. CONCLUSIONS: Fewer patients responded to GDHT than anticipated. Our data suggest that individual characteristics could predict the haemodynamic responses. CLINICAL TRIAL REGISTRATION: NCT01141894.

Randomized controlled trial of goal-directed haemodynamic treatment in patients with proximal femoral fracture.

BACKGROUND: Patients with proximal femoral fracture (PFF) are at high risk of postoperative complications. Goal-directed haemodynamic treatment (GDHT) in other high-risk surgical patients reduces postoperative complications. We aimed to compare effects of GDHT and routine fluid treatment (RFT) on postoperative outcomes after PFF surgery. METHODS: PFF patients (≥70 yr) were enrolled in this single-centre, open, randomized, controlled, parallel-group superiority trial with concealed allocation using computer-generated randomization. TREATMENTS: (i) GDHT to attain oxygen delivery index >600 ml min(-1) m(-2) using fluids and dobutamine and (ii) a protocol-guided RFT. After 150 enrolled patients, the trial was stopped due to slow recruitment. The short-term primary outcome measure was the relative risk (RR) of postoperative complications; secondary measures were (i) administered fluid levels, (ii) vasopressor requirements, and (iii) haemodynamic responses. RESULTS: For the GDHT group, 74 and for the RFT group 75 patients were designated. The RR of postoperative complications (GDHT vs RFT) was 0.79 (95% confidence interval 0.54-1.16); the volumes of i.v. fluids decreased (1078 vs 1440 ml, P=0.01); fewer patients required treatment of hypotension (18.5% vs 75%, P<0.005); there were more patients with increased oxygen delivery at the end of operation (28% vs 8%, P=0.04), but the haemodynamic goal was achieved in only 27% of patients in the GDHT group. CONCLUSIONS: The magnitude of risk reduction of postoperative complications is clinically relevant, but the trial was underpowered and the null hypothesis cannot be rejected.