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Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)

24 mars 2022 mis à jour par: Marie Kristine Jessen, MD

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Réel)

124

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
    • Central Denmark Region
      • Aarhus, Central Denmark Region, Danemark, 8200
        • Department of Emergency Medicine, Aarhus University Hospital
      • Randers, Central Denmark Region, Danemark, 8930
        • Department of Emergency Medicine, Regional Hospital Randers
      • Viborg, Central Denmark Region, Danemark, 8800
        • Department of Emergency Medicine, Regional Hospital Viborg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: 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.
Comparateur actif: 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
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
24-hour crystalloid iv. fluids
Délai: 24 hours from randomization
total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization
24 hours from randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Protocol violations
Délai: 24 hours from randomization
Feasibility measure: Number of patients with major protocol violations
24 hours from randomization
Screened-vs.-randomized-ratio
Délai: Through study completion, an average of 1 year
Feasibility measure: Number of patients screened vs included
Through study completion, an average of 1 year
Time to inclusion
Délai: Through study completion, an average of 1 year
Feasibility measure: Time from admission to inclusion/randomization (hours)
Through study completion, an average of 1 year
Lost-to-follow-up-rate
Délai: 24 hours from randomization
Feasibility measure: Number of patients lost to follow up in terms of 24-hour fluids
24 hours from randomization
Accumulated serious adverse reactions (SARs + SUSARs)
Délai: 7 days from randomization
Feasibility measure: Accumulated serious adverse reactions and events (SAEs + SARs+ SUSARs) within 7 days in-hospital
7 days from randomization
Total 24-hour fluids
Délai: 24 hours from randomization
Total fluids (oral and intravenous) at 24 hours
24 hours from randomization
Mortality
Délai: Total of 90-days
In-hospital, 30- and 90-days mortality
Total of 90-days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Marie Kristine Jessen, MD

Collaborateurs

Aarhus University Hospital
University of Aarhus
Viborg Regional Hospital
Randers Regional Hospital

Les enquêteurs

  • Chercheur principal: Marie K Jessen, MD, Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Denmark

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 novembre 2021

Achèvement primaire (Réel)

19 décembre 2021

Achèvement de l'étude (Réel)

19 mars 2022

Dates d'inscription aux études

Première soumission

11 septembre 2021

Première soumission répondant aux critères de contrôle qualité

30 septembre 2021

Première publication (Réel)

13 octobre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RECEM0001
  • 2021-000224-35 (Numéro EudraCT)
  • 1-10-72-163-21 (Autre identifiant: The Committee on Health Research Ethics, Central Denmark Region)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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