Norepinefrina no tratamento da hipotensão arterial induzida por anestesia geral em pacientes com insuficiência cardíaca crônica (NORAFLOW)
Avaliação da norepinefrina no manejo da hipotensão arterial induzida por anestesia geral em pacientes com insuficiência cardíaca crônica na sala de cirurgia.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: François LABASTE, Dr
- Número de telefone: +33 0561322822
- E-mail: labaste.f@chu-toulouse.fr
Locais de estudo
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Toulouse, França, 31400
- Recrutamento
- CHU Toulouse Rangueil
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Contato:
- François LABASTE, Dr
- Número de telefone: +33 0561322822
- E-mail: labaste.f@chu-toulouse.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population includes patients with heart failure and left ventricular failure with a ventricular ejection fraction less than or equal to 40%.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: François LABASTE, Dr, University Hospital, Toulouse
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RC31/24/0017
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