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

REFRESH trial investigators

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.

Original languageEnglish
JournalIntensive Care Medicine
DOIs
Publication statusE-pub ahead of print - 31 Oct 2018

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Resuscitation
Hypotension
Sepsis
Randomized Controlled Trials
Hospital Emergency Service
Blood Pressure
Intention to Treat Analysis
Random Allocation
Clinical Trials
Mortality

Cite this

@article{f39cb6d05b0542f6ba9d005c6fd0633b,
title = "Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH): a pilot randomised controlled trial",
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.",
author = "{REFRESH trial investigators} and Macdonald, {Stephen P J} and Gerben Keijzers and Taylor, {David McD} and Frances Kinnear and Glenn Arendts and Fatovich, {Daniel M} and Rinaldo Bellomo and David McCutcheon and Fraser, {John F} and Juan-Carlos Ascencio-Lane and Sally Burrows and Edward Litton and Amanda Harley and Matthew Anstey and Ashes Mukherjee",
year = "2018",
month = "10",
day = "31",
doi = "10.1007/s00134-018-5433-0",
language = "English",
journal = "Intensive Care Medicine",
issn = "0342-4642",
publisher = "Springer-Verlag London Ltd.",

}

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

In: Intensive Care Medicine, 31.10.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Restricted fluid resuscitation in suspected sepsis associated hypotension (REFRESH)

T2 - a pilot randomised controlled trial

AU - REFRESH trial investigators

AU - Macdonald, Stephen P J

AU - Keijzers, Gerben

AU - Taylor, David McD

AU - Kinnear, Frances

AU - Arendts, Glenn

AU - Fatovich, Daniel M

AU - Bellomo, Rinaldo

AU - McCutcheon, David

AU - Fraser, John F

AU - Ascencio-Lane, Juan-Carlos

AU - Burrows, Sally

AU - Litton, Edward

AU - Harley, Amanda

AU - Anstey, Matthew

AU - Mukherjee, Ashes

PY - 2018/10/31

Y1 - 2018/10/31

N2 - 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.

AB - 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.

U2 - 10.1007/s00134-018-5433-0

DO - 10.1007/s00134-018-5433-0

M3 - Article

JO - Intensive Care Medicine

JF - Intensive Care Medicine

SN - 0342-4642

ER -