Administration continue versus bolus de noradrénaline pour traiter l'hypotension post-induction (INDUCT-Multi)
24 juin 2026 mis à jour par: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
Administration Continue Versus Bolus de Noradrénaline pour Traiter l'Hypotension Post-Induction chez les Patients à Haut Risque en Chirurgie Non Cardiaque - L'Essai Multicentrique INDUCT (INDUCT-Multi)
INDUCT-Multi est un essai randomisé multicentrique qui étudie si l'administration continue, comparée à l'administration en bolus, de noradrénaline pendant l'induction de l'anesthésie générale réduit l'hypotension post-induction chez les patients à haut risque subissant une chirurgie non cardiaque.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
L'hypotension après l'induction de l'anesthésie générale, appelée hypotension post-induction, est fréquente chez les patients subissant une chirurgie non cardiaque et est associée à une lésion rénale aiguë. Les facteurs de risque d'hypotension post-induction comprennent un âge avancé, un statut physique plus élevé selon l'American Society of Anesthesiologists, une hypertension artérielle chronique - et des doses plus élevées de médicaments anesthésiques vasodilatateurs. Il est raisonnable de supposer qu'une gestion anesthésique prudente peut aider à maintenir la stabilité de la pression artérielle et à limiter l'hypotension post-induction. Conformément à cette hypothèse, la surveillance continue de la pression artérielle avec un cathéter artériel pendant l'induction de l'anesthésie générale aide les cliniciens à réduire l'hypotension post-induction - et est donc recommandée chez les patients de chirurgie non cardiaque à risque de complications liées à l'hypotension.
Outre la surveillance continue, les anesthésistes administrent systématiquement des vasopresseurs - tels que la noradrénaline - pour maintenir la pression artérielle. La noradrénaline est un vasopresseur à action rapide avec une demi-vie courte et est généralement administrée sous forme de bolus manuels répétés pendant l'induction de l'anesthésie générale. Administrée en bolus, elle augmente efficacement et rapidement la pression artérielle. Cependant, les bolus doivent être fréquemment répétés et bien synchronisés pour assurer la stabilité de la pression artérielle.
Dans un essai randomisé monocentrique, nous avons démontré que l'administration continue - comparée au bolus - de noradrénaline pendant l'induction de l'anesthésie générale aide à maintenir la stabilité de la pression artérielle chez les patients à haut risque de chirurgie non cardiaque. Nous visons maintenant à tester l'hypothèse que l'administration continue - comparée au bolus - de noradrénaline pendant l'induction de l'anesthésie générale réduit l'hypotension post-induction chez les patients à haut risque de chirurgie non cardiaque qui bénéficient d'une surveillance continue de la pression artérielle avec un cathéter artériel.
Type d'étude
Interventionnel
Inscription (Estimé)
446
Phase
- N'est pas applicable
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.
Coordonnées de l'étude
- Nom: Kristen K Thomsen, MD
- Numéro de téléphone: +4940741070215
- E-mail: kr.thomsen@uke.de
Lieux d'étude
-
-
-
Berlin, Allemagne
- Pas encore de recrutement
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
-
Contact:
- Sascha Treskatsch, MD
- Numéro de téléphone: +49 30 450 551 522
- E-mail: sascha.treskatsch@charite.de
-
Düsseldorf, Allemagne
- Recrutement
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
-
Contact:
- Sebastian Roth, MD
- Numéro de téléphone: +49 211 81 16253
- E-mail: Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg, Allemagne
- Recrutement
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
-
Contact:
- Kristen K Thomsen, MD
- Numéro de téléphone: +4940741070215
- E-mail: kr.thomsen@uke.de
-
München, Allemagne
- Recrutement
- Department of Anaesthesiology, University Hospital LMU Munich
-
Contact:
- Agnes Meidert, MD
- Numéro de téléphone: +49 89 440081065
- E-mail: Agnes.meidert@med.uni-muenchen.de
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-
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
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Critères d'inclusion :
Nous inclurons les patients consentants âgés de ≥45 ans programmés pour une chirurgie non cardiaque majeure élective sous anesthésie générale avec surveillance continue de la pression artérielle intra-artérielle prévue via un cathéter artériel radial et présentant au moins deux des critères de risque suivants pour développer une insuffisance rénale aiguë :
- Âge ≥65 ans
- État physique ASA III ou IV
- Hypertension artérielle chronique
- Diabète sucré nécessitant un traitement médicamenteux
- Chirurgie intra-abdominale
- Insuffisance rénale préopératoire (créatinine sérique ≥1,2 mg/dL)
Critères d'exclusion :
- Grossesse
- Arythmie cardiaque
- Antécédents d'hémorragie intracrânienne ou d'anévrisme intracrânien
- Indication clinique pour une perfusion continue de noradrénaline pendant l'induction de l'anesthésie générale (par exemple, sténose aortique sévère, maladie coronarienne ou insuffisance cardiaque)
- Patients incapables de comprendre, lire et donner un consentement éclairé en allemand
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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Administration continue de noradrénaline
Chez les patients assignés à l'administration continue de noradrénaline, la noradrénaline sera administrée en continu via une pompe à seringue.
|
Chez les patients assignés à l'administration continue de noradrénaline, une pompe à seringue sera préparée et connectée à un cathéter veineux périphérique ou central.
L'anesthésiste responsable démarrera la perfusion de noradrénaline et ajustera le débit de perfusion si nécessaire, et pourra administrer des bolus supplémentaires de noradrénaline via la pompe à seringue si cela est requis.
|
|
Aucune intervention: Administration de noradrénaline en bolus
Chez les patients assignés à l'administration de noradrénaline en bolus manuel, la noradrénaline sera administrée manuellement en doses de bolus.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area under a MAP of 50 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area under a MAP of 40 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 100 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 110 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 120 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 140 mmHg (mmHg x min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <65 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <60 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <50 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <40 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >100 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >110 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >120 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >140 mmHg (min)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Cumulative dose of norepinephrine indexed to body weight (µg kg-1)
Délai: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Acute kidney injury
Délai: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Nonfatal cardiac arrest
Délai: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Myocardial infarction
Délai: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Death
Délai: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
7 mai 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
31 mars 2026
Première soumission répondant aux critères de contrôle qualité
15 avril 2026
Première publication (Réel)
20 avril 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-101645-BO-ff
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
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