Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/17755
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dc.contributor.authorMacdonald, Stephen P J-
dc.contributor.authorTaylor, David McD-
dc.contributor.authorKeijzers, Gerben-
dc.contributor.authorArendts, Glenn-
dc.contributor.authorFatovich, Daniel M-
dc.contributor.authorKinnear, Frances B-
dc.contributor.authorBrown, Simon G A-
dc.contributor.authorBellomo, Rinaldo-
dc.contributor.authorBurrows, Sally-
dc.contributor.authorFraser, John F-
dc.contributor.authorLitton, Edward-
dc.contributor.authorAscencio-Lane, Juan Carlos-
dc.contributor.authorAnstey, Matthew-
dc.contributor.authorMcCutcheon, David-
dc.contributor.authorSmart, Lisa-
dc.contributor.authorVlad, Ioana-
dc.contributor.authorWinearls, James-
dc.contributor.authorWibrow, Bradley-
dc.date2017-
dc.date.accessioned2018-05-24T02:03:55Z-
dc.date.available2018-05-24T02:03:55Z-
dc.date.issued2017-08-29-
dc.identifier.citationTrials 2017; 18(1): 399-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/17755-
dc.description.abstractGuidelines recommend an initial intravenous (IV) fluid bolus of 30 ml/kg isotonic crystalloid for patients with sepsis and hypotension. However, there is a lack of evidence from clinical trials to support this. Accumulating observational data suggest harm associated with the injudicious use of fluids in sepsis. There is currently equipoise regarding liberal or restricted fluid-volume resuscitation as first-line treatment for sepsis-related hypotension. A randomised trial comparing these two approaches is, therefore, justified. The REstricted Fluid REsuscitation in Sepsis-associated Hypotension trial (REFRESH) is a multicentre, open-label, randomised, phase II clinical feasibility trial. Participants will be patients presenting to the emergency departments of Australian metropolitan hospitals with suspected sepsis and a systolic blood pressure of < 100 mmHg, persisting after a 1000-ml fluid bolus with isotonic crystalloid. Participants will be randomised to either a second 1000-ml fluid bolus (standard care) or maintenance rate fluid only, with the early commencement of a vasopressor infusion to maintain a mean arterial pressure of > 65 mmHg, if required (restricted fluid). All will receive further protocolised fluid boluses (500 ml or 250 ml, respectively), if required during the 6-h study period. The primary outcome measure is total volume administered in the first 6 h. Secondary outcomes include fluid volume at 24 h, organ support 'free days' to day 28, 90-day mortality, and a range of feasibility and process-of-care measures. Participants will also undergo serial measurement, over the first 24 h, of biomarkers of inflammation, endothelial cell activation and glycocalyx degradation for comparison between the groups. This is the first randomised trial examining fluid volume for initial resuscitation in septic shock in an industrialised country. A pragmatic, open-label design will establish the feasibility of undertaking a large, international, multicentre trial with sufficient power to assess clinical outcomes. The embedded biomarker study aims to provide mechanistic plausibility for a larger trial by defining the effects of fluid volume on markers of systemic inflammation and the vascular endothelium. Australia and New Zealand Clinical Trials Registry, ID: ACTRN12616000006448. Registered on 12 January 2016.-
dc.language.isoeng-
dc.subjectFluid therapy-
dc.subjectHypotension-
dc.subjectSepsis-
dc.titleREstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised controlled trial.-
dc.typeJournal Article-
dc.identifier.journaltitleTrials-
dc.identifier.affiliationCentre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, WA, Australia-
dc.identifier.affiliationDivision of Emergency Medicine, Medical School, University of Western Australia, Perth, WA, Australia-
dc.identifier.affiliationDepartment of Emergency Medicine, Austin Health, Heidelberg, Victoria, Australia-
dc.identifier.affiliationDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia-
dc.identifier.affiliationEmergency Department, Gold Coast University Hospital, Gold Coast, QLD, Australia-
dc.identifier.affiliationSchool of Medicine, Bond University, Gold Coast, QLD, Australia-
dc.identifier.affiliationSchool of Medical Sciences, Griffith University, Gold Coast, QLD, Australia-
dc.identifier.affiliationEmergency Department, Fiona Stanley Hospital, Perth, WA, Australia-
dc.identifier.affiliationEmergency Department, Royal Perth Hospital, Perth, WA, Australia-
dc.identifier.affiliationEmergency and Children's Services, The Prince Charles Hospital, Brisbane, QLD, Australia-
dc.identifier.affiliationEmergency Department, Royal Hobart Hospital, Hobart, TAS, Australia-
dc.identifier.affiliationIntensive Care Unit, Austin Health, Heidelberg, Victoria, Australia-
dc.identifier.affiliationSchool of Medicine, University of Melbourne, Melbourne, Victoria, Australia-
dc.identifier.affiliationSchool of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia-
dc.identifier.affiliationSchool of Medicine, University of Queensland, Brisbane, QLD, Australia-
dc.identifier.affiliationDepartment of Intensive Care, Fiona Stanley Hospital, Perth, WA, Australia-
dc.identifier.affiliationCritical Care Research Group, The Prince Charles Hospital, Brisbane, QLD, Australia-
dc.identifier.affiliationDepartment of Intensive Care, Sir Charles Gairdner Hospital, Perth, WA, Australia-
dc.identifier.affiliationEmergency Department, Armadale Health Service, Perth, WA, Australia-
dc.identifier.affiliationEmergency Department, Sir Charles Gairdner Hospital, Perth, WA, Australia-
dc.identifier.affiliationDepartment of Intensive Care, Gold Coast University Hospital, Gold Coast, QLD, Australia-
dc.identifier.doi10.1186/s13063-017-2137-7-
dc.identifier.orcid0000-0002-8986-9997-
dc.identifier.orcid0000-0002-1650-8939-
dc.identifier.pubmedid28851407-
dc.type.austinClinical Trial, Phase II-
dc.type.austinJournal Article-
dc.type.austinMulticenter Study-
dc.type.austinRandomized Controlled Trial-
local.name.researcherBellomo, Rinaldo
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptEmergency-
crisitem.author.deptIntensive Care-
crisitem.author.deptData Analytics Research and Evaluation (DARE) Centre-
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