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

ABSTRACT

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.