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Intensive Care Med. 2018 Dec;44(12):2070-2078. doi: 10.1007/s00134-018-5433-0. Epub 2018 Oct 31.

Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH): a pilot randomised controlled trial.

Author information

1
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia. stephen.macdonald@uwa.edu.au.
2
Medical School, University of Western Australia, Perth, Australia. stephen.macdonald@uwa.edu.au.
3
Emergency Department, Royal Perth Hospital, Perth, WA, Australia. stephen.macdonald@uwa.edu.au.
4
Emergency Department, Gold Coast University Hospital, Gold Coast, Australia.
5
School of Medicine, Bond University, Gold Coast, Australia.
6
School of Medical Sciences, Griffith University, Gold Coast, Australia.
7
Emergency Department, Austin Hospital, Melbourne, Australia.
8
Department of Medicine, University of Melbourne, Melbourne, Australia.
9
Emergency Department, The Prince Charles Hospital, Brisbane, Australia.
10
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia.
11
Medical School, University of Western Australia, Perth, Australia.
12
Emergency Department, Fiona Stanley Hospital, Perth, Australia.
13
Emergency Department, Royal Perth Hospital, Perth, WA, Australia.
14
Department of Intensive Care, Austin Hospital, Melbourne, Australia.
15
Emergency Department, Armadale-Kelmscott Memorial Hospital, Perth, Australia.
16
Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia.
17
Emergency Department, Royal Hobart Hospital, Hobart, Australia.
18
Department of Intensive Care, Fiona Stanley Hospital, Perth, Australia.
19
Department of Intensive Care, Sir Charles Gairdner Hospital, Perth, Australia.

Abstract

PURPOSE:

To 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.

METHODS:

A 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.

RESULTS:

There 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.

CONCLUSIONS:

A 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.

KEYWORDS:

Critical care; Emergency medicine; Fluid therapy; Resuscitation; Sepsis; Septic shock

PMID:
30382308
DOI:
10.1007/s00134-018-5433-0

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