Norépinéphrine dans la prise en charge de l'hypotension artérielle induite par l'anesthésie générale chez les patients atteints d'insuffisance cardiaque chronique (NORAFLOW)
Évaluation de la noradrénaline dans la prise en charge de l'hypotension artérielle induite par l'anesthésie générale chez les patients atteints d'insuffisance cardiaque chronique en salle d'opération.
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.
The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations. The potential indications for norepinephrine use are expanding due to dilution methods allowing peripheral catheter administration, particularly for addressing arterial hypotension during general anesthesia induction. However, these indications are primarily based on common practices, and the impact of norepinephrine on cardiac output in patients with chronic heart failure is poorly understood. The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: François LABASTE, Dr
- Numéro de téléphone: +33 0561322822
- E-mail: labaste.f@chu-toulouse.fr
Lieux d'étude
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Toulouse, France, 31400
- Recrutement
- CHU Toulouse Rangueil
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Contact:
- François LABASTE, Dr
- Numéro de téléphone: +33 0561322822
- E-mail: labaste.f@chu-toulouse.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population includes patients with heart failure and left ventricular failure with a ventricular ejection fraction less than or equal to 40%.
La description
Inclusion Criteria:
- Adult patients
- Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable.
- Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations.
- Scheduled surgery under general anesthesia.
- Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure).
- Postoperative monitoring planned in intensive care or intensive care
- Presence of controlled mechanical ventilation with tidal volumes between 8 and 10 ml/kg of ideal weight.
- Presence of arterial hypotension after induction of general anesthesia, and before surgical stimulation.
- Patient affiliated to a social security scheme or equivalent
- No opposition from the patient.
Exclusion Criteria:
- Chronic heart failure patients with right ventricular failure.
- Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt.
- Patients operated on under general anesthesia but maintaining spontaneous ventilation.
- Patients with respiratory compliance disorders with compliances greater than 30 cm of water.
- Patients with intra-abdominal hypertension.
- Patients with supraventricular or ventricular arrhythmia.
- Patients treated with catecholamines prior to the procedure.
- Patients operated on for urgent surgeries
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant or breastfeeding women.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Research procedures
Patients with heart failure |
During the surgery, the channels and monitoring equipment will be set up according to the usual procedure in the vascular surgery department. As part of the research, the Starling™ SV Sebac® electrodes will be installed (to measure cardiac flow, cardiac index (CI), stroke volume (VES), variations in stroke volume (VVES), and peripheral resistors (TPRI)). Once the equipment is in place, anesthetic induction will be carried out according to the usual protocol with curarization and mechanical ventilation. If the appearance of arterial hypotension is noted after anesthetic induction and mechanical ventilation, the patient will be definitively included in the study. As recommended, he will receive norepinephrine to treat hypotension. The measurements from the monitoring will be collected at 3, 5, and 10 min after the administration of norepinephrine. 10 days after admission to the operating room, hospitalization data will be collected. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction.
Délai: During the surgery.
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The evolution of the value of cardiac output assessed by non-invasive monitoring, using bioreactance: Starling™ SV Sebac®. |
During the surgery.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.
Délai: During the surgery.
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Measurement of pulse pressure difference. |
During the surgery.
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Evaluation of the impact of the norepinephrine bolus on blood pressure correction.
Délai: During the surgery.
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Evolution of the monitoring data: systolic blood pressure (SBP - mmHg). |
During the surgery.
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Evaluation of the impact of the norepinephrine bolus on heart rate.
Délai: During the surgery.
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Evolution of the monitoring data: heart rate (HR - bpm). |
During the surgery.
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Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.
Délai: For 10 days after surgery.
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Monitoring the appearance of side effects during post-operative hospitalization on the assessments usually carried out in the department and including. |
For 10 days after surgery.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François LABASTE, Dr, University Hospital, Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Autres numéros d'identification d'étude
- RC31/24/0017
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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