Liquide restreint ou libéral pour la réanimation hémodynamique dans le sepsis (FRESHLY)
Méta-analyse de la réanimation liquidienne dans le sepsis avec hypotension (FRESHLY) : méta-analyse des données individuelles des patients des essais ARISE FLUIDS, CLASSIC, CLOVERS et EVIS
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
The investigators will include four multicentre, open-label, randomised, clinical trials:
- Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942
- Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236
- Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028
- Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499
All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.
The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
All trials include adult patients requiring resuscitation for hypotension or hypoperfusion due to suspected sepsis as defined in the original studies. Participants may be enrolled in the emergency department, acute care ward or intensive care unit.
La description
Inclusion Criteria:
Participants of the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials who had:
- Suspected or proven infection
- Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
- Lactate ≥ 2.0 mmol/L
- Requirement for vasopressors to meet perfusion targets
Exclusion criteria:
Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Vasopressors
A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets |
A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets |
|
Fluids
A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required. |
A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
All-cause mortality at 90 days post randomisation
Délai: 90 days
|
Death from any cause at 90 days after randomisation |
90 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time from randomisation to death
Délai: Up to day 90
|
Time from randomisation to death |
Up to day 90
|
|
Incidence of mechanical ventilation
Délai: from randomisation until day 90 post-randomisation
|
Commencement of mechanical ventilation from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Incidence of acute renal replacement therapy
Délai: from randomisation until day 90 post-randomisation
|
Commencement of renal replacement therapy from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Days alive free of organ support at 28 days post randomisation
Délai: from randomisation until day 28 post-randomisation
|
days the patient is alive and receiving nil organ support from from randomisation until day 28 post-randomisation |
from randomisation until day 28 post-randomisation
|
|
Duration of hospital stay
Délai: From randomisation until day 90 post-randomisation
|
Length of time in hospital from randomisation until death or hospital discharge or day 90 post-randomisation |
From randomisation until day 90 post-randomisation
|
|
Incidence of serious adverse events
Délai: from randomisation until day 90 post-randomisation
|
Number of adverse events from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Duration of intensive care unit (ICU) stay
Délai: From randomisation until day 90 post-randomisation
|
Length of time in ICU from randomisation until death or hospital discharge or day 90 post-randomisation |
From randomisation until day 90 post-randomisation
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections
- État septique
- Syndrome de réponse inflammatoire systémique
- Inflammation
- Choc
- Conditions pathologiques, signes et symptômes
- Choc, Septique
- Thérapeutique
- Pharmacothérapie
- Actions pharmacologiques
- Actions et utilisations chimiques
- Utilisations thérapeutiques
- Agents cardiovasculaires
- Agents vasoconstricteurs
- Thérapie à liquide
Autres numéros d'identification d'étude
- FRESHLY V1
Informations sur les médicaments et les dispositifs, documents d'étude
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