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Br J Anaesth. 2013 Apr;110(4):545-53. doi: 10.1093/bja/aes468. Epub 2012 Dec 28.

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

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  • 1Karolinska Institute, CLINTEC, Division of Anaesthesiology, Karolinska University Hospital, Huddinge B31, Stockholm, Sweden. erzsebet.bartha@karolinska.se

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.

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PMID:
23274782
[PubMed - indexed for MEDLINE]
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