A randomised feasibility study to assess a novel strategy to rationalise fluid in patients after cardiac surgery

Abstract

Background: After cardiac surgery, patients receive large amounts of fluid in the Intensive Care Unit (ICU). We plan to conduct a multi-centre randomised controlled trial, of a conservative fluid regime, in patients after cardiac surgery, and have reported results of a feasibility study that evaluated efficacy and safety of the proposed regime.

Methods: After ethical approval, a single-centre, prospectively randomised interventional study was undertaken. Participants were randomised to either usual care, or to a protocolised algorithm, utilising stroke volume variation, to guide fluid administration to patients who were deemed to have inadequate cardiac output and were likely to be volume responsive. The study protocol lasted from ICU admission to de-sedation or 24 h, whichever occurred first.

Results: We randomised 144 subjects over 9 months. Less bolus fluid and less total overall fluid volume was administered in the intervention group (median (IQR) 1620 ml (500-3410) and 2525 ml (1440-5250; P<0.001), compared with the usual care group (2050 ml (910-4280) and 2980 ml (2070-6580; P=0.001), from ICU admission to extubation. There was no significant difference in incidence of acute kidney injury or the average amount of fluid administered to the usual care group at the beginning compared with the end of the study.

Conclusion: It is both possible and safe to achieve a significant reduction in the amount of fluid administered to patients, allocated to a conservative fluid protocol. These results suggest that a planned multi-centre study is both justified and feasible.

Clinical trial registration: Australia New Zealand Clinical Trials Registry www.anzctr.org.au (ACTRN12612000754842).

Keywords: acute kidney injury; cardiac output; cardiac surgery; haemodynamics; intensive care units.