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Trial record 1 of 1 for:    jessen | sepsis
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Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)

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ClinicalTrials.gov Identifier: NCT05076435
Recruitment Status : Completed
First Posted : October 13, 2021
Last Update Posted : March 25, 2022
Sponsor:
Collaborators:
University of Aarhus
Aarhus University Hospital
Viborg Regional Hospital
Randers Regional Hospital
Information provided by (Responsible Party):
Marie Kristine Jessen, MD, University of Aarhus

Brief Summary:
This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis allocated to two different IV fluid regimens enrolled at three emergency departments in Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume within 24 hours and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day mortality.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Isotonic crystalloids Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)
Actual Study Start Date : November 3, 2021
Actual Primary Completion Date : December 19, 2021
Actual Study Completion Date : March 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Restrictive fluid administration

No IV fluids unless one of the extenuating circumstances occur;

  1. In case of severe hypoperfusion or severe circulatory impairment defined by either: 1) Lactate≥4 mmol/L, 2) Hypotension (systolic BP < 90 mmHg), 3) Mottling beyond the kneecap (mottling score >2) OR 4) Urinary output<0.1 mL/kg bodyweight/h (only in the first 4hrs after randomization) then a bolus of 250 ml of IV crystalloid solution may be given followed by re-evaluation
  2. In case of overt fluid losses (e.g. vomiting, large aspirates,) IV fluid may be given to correct for the loss, but not above the volume lost.
  3. In case the oral/enteral route for water or electrolyte solutions is contraindicated or has failed, IV fluids may be given to:

    Correct dehydration or electrolyte deficiencies Ensure a total fluid input of 1 L in 24hrs

  4. IV fluids may be given as carrier for medication, but with lowest possible volume
Drug: Isotonic crystalloids

Types of fluids in both intervention groups:

  • Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
  • Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
  • Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.

Active Comparator: Usual care (standard care)

There will be no upper limit for the use of either IV or oral/enteral fluids

  1. IV fluids should be given in the case of hypoperfusion or circulatory impairment and should be continued as long as hemodynamic variables improve including static or dynamic variable(s) as chosen by the clinicians. These criteria are based on the Surviving Sepsis Campaign guideline.
  2. IV fluids should be given as maintenance if the ICU has a protocol recommending maintenance fluid
  3. IV fluids should be given to substitute expected or observed loss, dehydration or electrolyte derangements
Drug: Isotonic crystalloids

Types of fluids in both intervention groups:

  • Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
  • Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
  • Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.




Primary Outcome Measures :
  1. 24-hour crystalloid iv. fluids [ Time Frame: 24 hours from randomization ]
    total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization


Secondary Outcome Measures :
  1. Protocol violations [ Time Frame: 24 hours from randomization ]
    Feasibility measure: Number of patients with major protocol violations

  2. Screened-vs.-randomized-ratio [ Time Frame: Through study completion, an average of 1 year ]
    Feasibility measure: Number of patients screened vs included

  3. Time to inclusion [ Time Frame: Through study completion, an average of 1 year ]
    Feasibility measure: Time from admission to inclusion/randomization (hours)

  4. Lost-to-follow-up-rate [ Time Frame: 24 hours from randomization ]
    Feasibility measure: Number of patients lost to follow up in terms of 24-hour fluids

  5. Accumulated serious adverse reactions (SARs + SUSARs) [ Time Frame: 7 days from randomization ]
    Feasibility measure: Accumulated serious adverse reactions and events (SAEs + SARs+ SUSARs) within 7 days in-hospital

  6. Total 24-hour fluids [ Time Frame: 24 hours from randomization ]
    Total fluids (oral and intravenous) at 24 hours

  7. Mortality [ Time Frame: Total of 90-days ]
    In-hospital, 30- and 90-days mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All of the below must be fulfilled:

  1. Unplanned emergency department admission
  2. Age ≥ 18 years
  3. Sepsis defined as

    1. suspected infection by the treating clinician AND
    2. blood cultures drawn AND
    3. IV antibiotics administered or planned AND
    4. An infection related increase of SOFA*-score ≥ 2 from baseline
  4. 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:

  1. ≥ 500 ml of fluids given prior to randomization
  2. Invasively ventilated or vasopressors initiated at the time of screening
  3. Known or suspected severe bleeding judged by the treating clinician
  4. Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
  5. Prior enrollment in the trial
  6. Patients, who the clinician expect not to survive the next 24-hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076435


Locations
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Denmark
Department of Emergency Medicine, Aarhus University Hospital
Aarhus, Central Denmark Region, Denmark, 8200
Department of Emergency Medicine, Regional Hospital Randers
Randers, Central Denmark Region, Denmark, 8930
Department of Emergency Medicine, Regional Hospital Viborg
Viborg, Central Denmark Region, Denmark, 8800
Sponsors and Collaborators
Marie Kristine Jessen, MD
University of Aarhus
Aarhus University Hospital
Viborg Regional Hospital
Randers Regional Hospital
Investigators
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Principal Investigator: Marie K Jessen, MD Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie Kristine Jessen, MD, Principal Investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT05076435    
Other Study ID Numbers: RECEM0001
2021-000224-35 ( EudraCT Number )
1-10-72-163-21 ( Other Identifier: The Committee on Health Research Ethics, Central Denmark Region )
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie Kristine Jessen, MD, University of Aarhus:
Sepsis
Hypotension
IV fluid therapy
Fluid resuscitation
Emergency Department
Crystalloids
Additional relevant MeSH terms:
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Sepsis
Toxemia
Emergencies
Disease Attributes
Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome
Inflammation