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- Klinische proef NCT05076435
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)
Studie Overzicht
Gedetailleerde beschrijving
BACKGROUND:
Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.
OBJECTIVES:
The aim of the REFACED Sepsis trial is to test if an IV fluid restrictive protocol in ED patients with sepsis is feasible, i.e., if the protocol decreases the IV fluid volumes administered.
DESIGN:
REFACED Sepsis is a multicenter, randomized, parallel-group, open-labeled, feasibility trial
POPULATION:
ED patients with sepsis expected to be admitted for ≥ 24 hours
EXPERIMENTAL INTERVENTION:
In the IV fluid restriction group no IV fluids should be given unless one of the below mentioned occurs;
A fluid bolus of 250 ml isotonic crystalloid may be given within 15 minutes if one of the following occurs (hypoperfusion criteria):
- Lactate concentration ≥ 4 mmol/l (arterial or venous blood gas/blood sample)
- Hypotension (systolic BP < 90 mmHg)
- Mottling beyond edge of kneecap (i.e., Mottling score >2)53
- Severe oliguria, i.e., diuresis < 0.1 ml/kg/h, during the first 4 hours of admission
All patients will be ensured min. 1 L of oral/intravenous fluids in 24 hours and electrolytes can be corrected.
CONTROL INTERVENTION:
In the usual care group there will be no upper limit for the use of IV fluids.
OUTCOMES:
The primary outcome is 24-hour intravenous crystalloid fluid administration. Key secondary outcomes are: Feasibility measures: Number of patients with major protocol violations, Number of patients screened vs included, Time from admission to inclusion, Number of patients lost to follow up in terms of 24-hour fluids, Accumulated serious adverse reactions and events (SAEs + Suspected Unexpected Serious Adverse Reaction (SUSARs)) within 48 hours in-hospital, Total fluids (oral and intravenous) at 24 hours,
TRIAL-SIZE:
124 patients will be randomized to restrictive fluid administration or usual care within 24 hours of randomization
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Central Denmark Region
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Aarhus, Central Denmark Region, Denemarken, 8200
- Department of Emergency Medicine, Aarhus University Hospital
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Randers, Central Denmark Region, Denemarken, 8930
- Department of Emergency Medicine, Regional Hospital Randers
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Viborg, Central Denmark Region, Denemarken, 8800
- Department of Emergency Medicine, Regional Hospital Viborg
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria: All of the below must be fulfilled:
- Unplanned emergency department admission
- Age ≥ 18 years
Sepsis defined as
- suspected infection by the treating clinician AND
- blood cultures drawn AND
- IV antibiotics administered or planned AND
- An infection related increase of SOFA*-score ≥ 2 from baseline
Expected hospital stay > 24 hours as deemed by treating clinician
- Sequential Organ Failure Assessment (SOFA) Score
Further more the patient must fulfill criteria for enrollment in an acute study according to Danish law
Exclusion Criteria: We will exclude patients fulfilling any of following exclusion criteria:
- ≥ 500 ml of fluids given prior to randomization
- Invasively ventilated or vasopressors initiated at the time of screening
- Known or suspected severe bleeding judged by the treating clinician
- Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
- Prior enrollment in the trial
- Patients, who the clinician expect not to survive the next 24-hours
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Restrictive fluid administration
No IV fluids unless one of the extenuating circumstances occur;
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Types of fluids in both intervention groups:
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Actieve vergelijker: Usual care (standard care)
There will be no upper limit for the use of either IV or oral/enteral fluids
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Types of fluids in both intervention groups:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
24-hour crystalloid iv. fluids
Tijdsspanne: 24 hours from randomization
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total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization
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24 hours from randomization
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Protocol violations
Tijdsspanne: 24 hours from randomization
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Feasibility measure: Number of patients with major protocol violations
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24 hours from randomization
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Screened-vs.-randomized-ratio
Tijdsspanne: Through study completion, an average of 1 year
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Feasibility measure: Number of patients screened vs included
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Through study completion, an average of 1 year
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Time to inclusion
Tijdsspanne: Through study completion, an average of 1 year
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Feasibility measure: Time from admission to inclusion/randomization (hours)
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Through study completion, an average of 1 year
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Lost-to-follow-up-rate
Tijdsspanne: 24 hours from randomization
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Feasibility measure: Number of patients lost to follow up in terms of 24-hour fluids
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24 hours from randomization
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Accumulated serious adverse reactions (SARs + SUSARs)
Tijdsspanne: 7 days from randomization
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Feasibility measure: Accumulated serious adverse reactions and events (SAEs + SARs+ SUSARs) within 7 days in-hospital
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7 days from randomization
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Total 24-hour fluids
Tijdsspanne: 24 hours from randomization
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Total fluids (oral and intravenous) at 24 hours
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24 hours from randomization
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Mortality
Tijdsspanne: Total of 90-days
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In-hospital, 30- and 90-days mortality
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Total of 90-days
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Marie K Jessen, MD, Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Denmark
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RECEM0001
- 2021-000224-35 (EudraCT-nummer)
- 1-10-72-163-21 (Andere identificatie: The Committee on Health Research Ethics, Central Denmark Region)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Sepsis
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University of Kansas Medical CenterUniversity of KansasWervingSepsis | Septische shock | Sepsis-syndroom | Sepsis, ernstig | Sepsis Bacterieel | Sepsis-bacteriëmieVerenigde Staten
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Jip GroenInBiomeWervingMicrobiële kolonisatie | Neonatale infectie | Neonatale sepsis, vroege aanvang | Microbiële ziekte | Klinische sepsis | Kweeknegatieve neonatale sepsis | Neonatale sepsis, late aanvang | Kweek positieve neonatale sepsisNederland
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The University of QueenslandRoyal Brisbane and Women's HospitalOnbekend
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Karolinska InstitutetÖrebro University, SwedenVoltooidSepsis | Sepsis-syndroom | Sepsis, ernstigZweden
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Ohio State UniversityVoltooidSepsis, ernstige sepsis en septische shockVerenigde Staten
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsVoltooidSepsis | Septische shock | Ernstige sepsis | Sepsis-syndroomVerenigd Koninkrijk
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityWervingErnstige sepsis | Ernstige sepsis zonder septische shockVerenigde Staten
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Indonesia UniversityVoltooidErnstige sepsis met septische shock | Ernstige sepsis zonder septische shockIndonesië
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital en andere medewerkersVoltooidSepsis | Septische shock | Ernstige sepsis | Infectie | Sepsis-syndroomVerenigde Staten
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Inverness Medical InnovationsVoltooidSepsis | Systemisch ontstekingsreactiesyndroom | Ernstige sepsis | Sepsis-syndroomVerenigde Staten
Klinische onderzoeken op Isotonic crystalloids
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University Hospital Inselspital, BerneVoltooidBloedverlies, chirurgisch | VloeistofretentieZwitserland
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İlke KarabıyıkVoltooidOrthopedische aandoening | Postoperatieve pijnKalkoen