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.