Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED):  A multicenter, randomized feasibility trial

Marie K Jessen; Lars W Andersen; Marie-Louise H Thomsen; Peter Kristensen; Wazhma Hayeri; Ranva E Hassel; Tina G Messerschmidt; Christoffer G Sølling; Anders Perner; Jens Aage K Petersen; Hans Kirkegaard

doi:10.1111/acem.14546

Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial

Marie K Jessen^*, Lars W Andersen, Marie-Louise H Thomsen, Peter Kristensen, Wazhma Hayeri, Ranva E Hassel, Tina G Messerschmidt, Christoffer G Sølling, Anders Perner, Jens Aage K Petersen, Hans Kirkegaard

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

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Abstract

BACKGROUND: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous volumes. We aimed to determine if a 24-hour protocol restricting intravenous (IV) fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED).

METHODS: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 hours of restrictive IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if pre-defined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 hours after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes.

RESULTS: We included 123 patients (restrictive: 61 patients and standard care: 62 patients) in the primary analysis. 32% (95% confidence interval (CI) 28% to 37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24-hours, the mean IV crystalloid fluid volumes were 562 ml (standard deviation (SD): 1076) vs. 1370 ml (SD: 1438) in the restrictive vs. standard care group (mean difference -801 ml (95% CI: -1257 to -345), p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality.

CONCLUSIONS: A protocol restricting IV crystalloid fluids in emergency department patients with sepsis reduced 24-hour fluid volumes compared to standard care. A future trial powered towards patient-centered outcomes appears feasible.

Originalsprog	Engelsk
Tidsskrift	Academic Emergency Medicine
Vol/bind	29
Nummer	10
Sider (fra-til)	1172-1184
Antal sider	13
ISSN	1069-6563
DOI	https://doi.org/10.1111/acem.14546
Status	Udgivet - okt. 2022

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10.1111/acem.14546Licens: CC BY-NC-ND

Academic Emergency Medicine - 2022 - Jessen - Restrictive fluids versus standard care in adults with sepsis in theForlagets udgivne version, 2,21 MBLicens: CC BY-NC-ND

Citationsformater

Jessen, M. K., Andersen, L. W., Thomsen, M.-L. H., Kristensen, P., Hayeri, W., Hassel, R. E., Messerschmidt, T. G., Sølling, C. G., Perner, A., Petersen, J. A. K., & Kirkegaard, H. (2022). Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial. Academic Emergency Medicine, 29(10), 1172-1184. https://doi.org/10.1111/acem.14546

@article{d0157d43b470431cb7ef924c30cb0bbf,

title = "Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial",

abstract = "BACKGROUND: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous volumes. We aimed to determine if a 24-hour protocol restricting intravenous (IV) fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED).METHODS: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 hours of restrictive IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if pre-defined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 hours after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes.RESULTS: We included 123 patients (restrictive: 61 patients and standard care: 62 patients) in the primary analysis. 32% (95% confidence interval (CI) 28% to 37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24-hours, the mean IV crystalloid fluid volumes were 562 ml (standard deviation (SD): 1076) vs. 1370 ml (SD: 1438) in the restrictive vs. standard care group (mean difference -801 ml (95% CI: -1257 to -345), p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality.CONCLUSIONS: A protocol restricting IV crystalloid fluids in emergency department patients with sepsis reduced 24-hour fluid volumes compared to standard care. A future trial powered towards patient-centered outcomes appears feasible.",

keywords = "CAMPAIGN INTERNATIONAL GUIDELINES, GOAL-DIRECTED THERAPY, IN-HOSPITAL MORTALITY, MANAGEMENT, OUTCOMES, OVERLOAD, PROTOCOL, RESUSCITATION, SEPTIC SHOCK",

author = "Jessen, {Marie K} and Andersen, {Lars W} and Thomsen, {Marie-Louise H} and Peter Kristensen and Wazhma Hayeri and Hassel, {Ranva E} and Messerschmidt, {Tina G} and S{\o}lling, {Christoffer G} and Anders Perner and Petersen, {Jens Aage K} and Hans Kirkegaard",

year = "2022",

month = oct,

doi = "10.1111/acem.14546",

language = "English",

volume = "29",

pages = "1172--1184",

journal = "Academic Emergency Medicine",

issn = "1069-6563",

publisher = "Wiley-Blackwell Publishing, Inc.",

number = "10",

}

Jessen, MK , Andersen, LW , Thomsen, M-LH , Kristensen, P, Hayeri, W, Hassel, RE, Messerschmidt, TG, Sølling, CG, Perner, A, Petersen, JAK & Kirkegaard, H 2022, 'Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial', Academic Emergency Medicine, bind 29, nr. 10, s. 1172-1184. https://doi.org/10.1111/acem.14546

Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial. / Jessen, Marie K ; Andersen, Lars W ; Thomsen, Marie-Louise H et al.
I: Academic Emergency Medicine, Bind 29, Nr. 10, 10.2022, s. 1172-1184.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED)

T2 - A multicenter, randomized feasibility trial

AU - Jessen, Marie K

AU - Andersen, Lars W

AU - Thomsen, Marie-Louise H

AU - Kristensen, Peter

AU - Hayeri, Wazhma

AU - Hassel, Ranva E

AU - Messerschmidt, Tina G

AU - Sølling, Christoffer G

AU - Perner, Anders

AU - Petersen, Jens Aage K

AU - Kirkegaard, Hans

PY - 2022/10

Y1 - 2022/10

N2 - BACKGROUND: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous volumes. We aimed to determine if a 24-hour protocol restricting intravenous (IV) fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED).METHODS: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 hours of restrictive IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if pre-defined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 hours after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes.RESULTS: We included 123 patients (restrictive: 61 patients and standard care: 62 patients) in the primary analysis. 32% (95% confidence interval (CI) 28% to 37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24-hours, the mean IV crystalloid fluid volumes were 562 ml (standard deviation (SD): 1076) vs. 1370 ml (SD: 1438) in the restrictive vs. standard care group (mean difference -801 ml (95% CI: -1257 to -345), p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality.CONCLUSIONS: A protocol restricting IV crystalloid fluids in emergency department patients with sepsis reduced 24-hour fluid volumes compared to standard care. A future trial powered towards patient-centered outcomes appears feasible.

AB - BACKGROUND: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous volumes. We aimed to determine if a 24-hour protocol restricting intravenous (IV) fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED).METHODS: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 hours of restrictive IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if pre-defined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 hours after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes.RESULTS: We included 123 patients (restrictive: 61 patients and standard care: 62 patients) in the primary analysis. 32% (95% confidence interval (CI) 28% to 37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24-hours, the mean IV crystalloid fluid volumes were 562 ml (standard deviation (SD): 1076) vs. 1370 ml (SD: 1438) in the restrictive vs. standard care group (mean difference -801 ml (95% CI: -1257 to -345), p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality.CONCLUSIONS: A protocol restricting IV crystalloid fluids in emergency department patients with sepsis reduced 24-hour fluid volumes compared to standard care. A future trial powered towards patient-centered outcomes appears feasible.

KW - CAMPAIGN INTERNATIONAL GUIDELINES

KW - GOAL-DIRECTED THERAPY

KW - IN-HOSPITAL MORTALITY

KW - MANAGEMENT

KW - OUTCOMES

KW - OVERLOAD

KW - PROTOCOL

KW - RESUSCITATION

KW - SEPTIC SHOCK

U2 - 10.1111/acem.14546

DO - 10.1111/acem.14546

M3 - Journal article

C2 - 35652491

SN - 1069-6563

VL - 29

SP - 1172

EP - 1184

JO - Academic Emergency Medicine

JF - Academic Emergency Medicine

IS - 10

ER -

Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial

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