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Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE): a protocol for a multicentre feasibility trial
Lund Univ, Helsingborg Hosp, Dept Clin Sci Lund, Anesthesiol & Intens Care, Helsingborg, Sweden..
Lund Univ, Helsingborg Hosp, Dept Clin Sci Lund, Anesthesiol & Intens Care, Helsingborg, Sweden..
Lund Univ, Skane Univ Hosp, Dept Clin Sci Lund, Neurol, Lund, Sweden..
Copenhagen Univ Hosp, Ctr Clin Intervent Res, Copenhagen Trial Unit, Copenhagen, Denmark.;Copenhagen Univ Hosp, Neurosci Ctr, Dept Neuroanaesthesiol, Copenhagen, Denmark..
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2023 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 13, no 2, article id e065392Article in journal (Refereed) Published
Abstract [en]

Introduction: Administration of large volumes of fluids is associated with poor outcome in septic shock. Recent data suggest that non-resuscitation fluids are the major source of fluids in the intensive care unit (ICU) patients suffering from septic shock. The present trial is designed to test the hypothesis that a protocol targeting this source of fluids can reduce fluid administration compared with usual care.

Methods and analysis: The design will be a multicentre, randomised, feasibility trial. Adult patients admitted to ICUs with septic shock will be randomised within 12 hours of admission to receive non-resuscitation fluids either according to a restrictive protocol or to receive usual care. The healthcare providers involved in the care of participants will not be blinded. The participants, outcome assessors at the 6-month follow-up and statisticians will be blinded. Primary outcome will be litres of fluids administered within 3 days of randomisation. Secondary outcomes will be proportion of randomised participants with outcome data on all-cause mortality; days alive and free of mechanical ventilation within 90 days of inclusion; any acute kidney injury and ischaemic events in the ICU (cerebral, cardiac, intestinal or limb ischaemia); proportion of surviving randomised patients who were assessed by European Quality of Life 5-Dimensions 5-Level questionnaire and Montreal Cognitive Assessment; proportion of all eligible patients who were randomised and proportion of participants experiencing at least one protocol violation.

Place, publisher, year, edition, pages
BMJ PUBLISHING GROUP BMJ Publishing Group Ltd, 2023. Vol. 13, no 2, article id e065392
Keywords [en]
adult intensive & critical care, infectious diseases
National Category
Anesthesiology and Intensive Care
Identifiers
URN: urn:nbn:se:uu:diva-501162DOI: 10.1136/bmjopen-2022-065392ISI: 000944467100075PubMedID: 36854601OAI: oai:DiVA.org:uu-501162DiVA, id: diva2:1755013
Available from: 2023-05-05 Created: 2023-05-05 Last updated: 2024-01-15Bibliographically approved

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Lipcsey, Miklós

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