• Macdonald Stephen P J SPJ Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia. stephen.macdonald@uwa.edu.au., Gerben Keijzers, David McD Taylor, Frances Kinnear, Glenn Arendts, Daniel M Fatovich, Rinaldo Bellomo, David McCutcheon, John F Fraser, Juan-Carlos Ascencio-Lane, Sally Burrows, Edward Litton, Amanda Harley, Matthew Anstey, Ashes Mukherjee, and REFRESH trial investigators.
• Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia. stephen.macdonald@uwa.edu.au.
• Intensive Care Med. 2018 Dec 1; 44 (12): 2070-2078.

PurposeTo determine if a regimen of restricted fluids and early vasopressor compared to usual care is feasible for initial resuscitation of hypotension due to suspected sepsis.MethodsA prospective, randomised, open-label, clinical trial of a restricted fluid resuscitation regimen in the first 6 h among patients in the emergency department (ED) with suspected sepsis and a systolic blood pressure under 100 mmHg, after minimum 1000 ml of IV fluid. Primary outcome was total fluid administered within 6 h post randomisation.ResultsThere were 99 participants (50 restricted volume and 49 usual care) in the intention-to-treat analysis. Median volume from presentation to 6 h in the restricted volume group was 2387 ml [first to third quartile (Q1-Q3) 1750-2750 ml]; 30 ml/kg (Q1-Q3 32-39 ml/kg) vs. 3000 ml (Q1-Q3 2250-3900 ml); 43 ml/kg (Q1-Q3 35-50 ml/kg) in the usual care group (p < 0.001). Median duration of vasopressor support was 21 h (Q1-Q3 9-42 h) vs. 33 h (Q1-Q3 15-50 h), (p = 0.13) in the restricted volume and usual care groups, respectively. At 90-days, 4 of 48 (8%) in the restricted volume group and 3 of 47 (6%) in the usual care group had died. Protocol deviations occurred in 6/50 (12%) in restricted group and 11/49 (22%) in the usual care group, and serious adverse events in four cases (8%) in each group.ConclusionsA regimen of restricted fluids and early vasopressor in ED patients with suspected sepsis and hypotension appears feasible. Illness severity was moderate and mortality rates low. A future trial is necessary with recruitment of high-risk patients to determine effects on clinical outcomes in this setting.

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