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Erschienen in: Intensive Care Medicine 12/2018

31.10.2018 | Original

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

verfasst von: Stephen P. J. Macdonald, 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, for the REFRESH trial investigators

Erschienen in: Intensive Care Medicine | Ausgabe 12/2018

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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.
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Metadaten
Titel
Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH): a pilot randomised controlled trial
verfasst von
Stephen P. J. Macdonald
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
for the REFRESH trial investigators
Publikationsdatum
31.10.2018
Verlag
Springer Berlin Heidelberg
Erschienen in
Intensive Care Medicine / Ausgabe 12/2018
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-018-5433-0

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