OBJECTIVES:: Fluid responsiveness is proposed as a physiology-based method to titrate fluid therapy based on preload dependence. The objectives of this study were to determine if: 1) a fluid responsiveness protocol would decrease progression of organ dysfunction; and, 2) a fluid responsiveness protocol would facilitate a more aggressive resuscitation. METHODS:: Prospective, 10-center, randomized interventional trial. Inclusion criteria: a) suspected sepsis and lactate 2.0–4.0?mmol/l. Exclusion criteria (abbreviated): a) SBP10% increase in stroke volume in response to 5?cc/kg fluid bolus) with balance of a liter given in responsive patients.. Control: standard clinical care. Outcomes: primary - change in SOFA >=1 over 72?hours; secondary - fluids administered. Trial was initially powered at 600 patients, but stopped early due to a change in sponsorʼs funding priorities. RESULTS:: Sixty-four patients were enrolled with 32 in the treatment arm. There were no significant differences between arms in age, co-morbidities, baseline vital signs or SOFA scores (p?>?0.05 for all). Comparing treatment vs SOC - there was no difference in increase in SOFA >= 1 (30% vs 33%) [n.b. underpowered, p?=?1.0] or pre-protocol fluids 1050cc (95%CI 786–1314) vs 1031 cc (741–1325) (p?=?0.93); however, treatment patients received more fluids during the protocol [2633cc (2264–3001) vs 1002cc (707–1298)] (p?
ASJC Scopus subject areas
- Critical Care and Intensive Care Medicine
- Emergency Medicine