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Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)—protocol for a multicenter, randomized, clinical, proof-of-concept trial

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DOI

  • Marie Kristine Jessen
  • Lars Wiuff Andersen
  • Marie Louise Holm Thomsen
  • Peter Kristensen
  • Wazhma Hayeri
  • Ranva Espegård Hassel
  • Anders Perner
  • Jens Aage Kølsen Petersen
  • Hans Kirkegaard
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Background: Intravenous fluids are often used in the treatment of sepsis. The better strategy regarding fluid volume is debated, but preliminary data in patients with septic shock or sepsis-related hypotension favor restrictive fluid administration. We describe the protocol and statistical analysis plan for the Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)—a multicenter, randomized clinical proof-of-concept trial. The aim of the REFACED Sepsis trial is to test if a restrictive intravenous fluid protocol in emergency department patients with sepsis without shock is feasible and decreases the intravenous fluid volume administered in comparison to standard care. Methods: This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of crystalloid fluid within 24 h in 124 patients with sepsis without shock enrolled at three emergency departments in the Central Denmark Region. Patients are allocated to two different intravenous fluid regimens: a restrictive approach using four trigger criteria for fluid administration vs. standard care. The primary, feasibility outcome is total intravenous, crystalloid fluid volume within 24 h, and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 h, and serious adverse reactions and suspected unexpected serious adverse reactions. Status: The trial started in November 2021, and the last patient is anticipated to be included in January 2022. Discussion: Sepsis is very common in emergency department patients and fluid administration is very frequently administered in these patients. However, the evidence to guide fluid administration is very sparse. This feasibility trial will be the foundation for a potential future large-scale trial investigating restrictive vs. standard fluid administration in patients with sepsis. Trial registration: EudraCT number: 2021-000224-35 (date: 2021 May 03), ClinicalTrials.gov number: NCT05076435 (date: 2021 October 13), Committee on Health Research Ethics – Central Denmark Region: 1-10-72-163-21 (date: 2021 June 28).

OriginalsprogEngelsk
Artikelnummer75
TidsskriftPilot and Feasibility Studies
Vol/bind8
Udgave nummer1
ISSN2055-5784
DOI
StatusUdgivet - dec. 2022

Bibliografisk note

Funding Information:
Funding for the trial is provided by Carl and Ellen Hertz foundation (DKK 15,000), Frimodt-Heineke Foundation (DKK 25,000), Ruth & Holger Hesses Memorial Fund (DKK 60,000), Health Research Foundation of Central Denmark Region (DKK 215,000), “Akutpuljen” Central Denmark Region (DKK 582,000), and Aarhus University (salary for primary investigator, DKK 1.5 mio). The funding agencies have no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.

Publisher Copyright:
© 2022, The Author(s).

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