Administração Contínua Versus Em Bolus de Norepinefrina para Tratar Hipotensão Pós-Indução (INDUCT-Multi)
24 de junho de 2026 atualizado por: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
Administração Contínua Versus em Bolus de Norepinefrina para Tratar Hipotensão Pós-Indução em Doentes de Alto Risco Submetidos a Cirurgia Não-Cardíaca - O Estudo Multicêntrico INDUCT (INDUCT-Multi)
O INDUCT-Multi é um ensaio multicêntrico randomizado que investiga se a administração contínua, em comparação com a em bolus, de norepinefrina durante a indução da anestesia geral reduz a hipotensão pós-indução em doentes de alto risco submetidos a cirurgia não cardíaca.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
A hipotensão após a indução da anestesia geral, referida como hipotensão pós-indução, é comum em doentes submetidos a cirurgia não cardíaca e está associada a lesão renal aguda. Os fatores de risco para a hipotensão pós-indução incluem idade avançada, estado físico mais elevado segundo a Sociedade Americana de Anestesiologistas, hipertensão arterial crónica - e doses mais elevadas de fármacos anestésicos vasodilatadores. É razoável assumir que uma gestão anestésica cuidadosa pode ajudar a manter a estabilidade da pressão arterial e limitar a hipotensão pós-indução. De acordo com esta suposição, a monitorização contínua da pressão arterial com um cateter arterial durante a indução da anestesia geral ajuda os clínicos a reduzir a hipotensão pós-indução - e é, portanto, recomendada em doentes de cirurgia não cardíaca com risco de complicações relacionadas com hipotensão.
Além da monitorização contínua, os anestesiologistas administram rotineiramente vasopressores - como a norepinefrina - para manter a pressão arterial. A norepinefrina é um vasopressor de ação rápida com uma meia-vida curta e é geralmente administrada como bolus manuais repetidos durante a indução da anestesia geral. Administrada como bolus, aumenta eficaz e rapidamente a pressão arterial. No entanto, os bolus precisam de ser frequentemente repetidos e bem cronometrados para garantir a estabilidade da pressão arterial.
Num ensaio aleatorizado de centro único, demonstramos que a administração contínua - em comparação com bolus - de norepinefrina durante a indução da anestesia geral ajuda a manter a estabilidade da pressão arterial em doentes de alto risco submetidos a cirurgia não cardíaca. Agora pretendemos testar a hipótese de que a administração contínua - em comparação com bolus - de norepinefrina durante a indução da anestesia geral reduz a hipotensão pós-indução em doentes de alto risco submetidos a cirurgia não cardíaca que têm monitorização contínua da pressão arterial com um cateter arterial.
Tipo de estudo
Intervencional
Inscrição (Estimado)
446
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kristen K Thomsen, MD
- Número de telefone: +4940741070215
- E-mail: kr.thomsen@uke.de
Locais de estudo
-
-
-
Berlin, Alemanha
- Ainda não está recrutando
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
-
Contato:
- Sascha Treskatsch, MD
- Número de telefone: +49 30 450 551 522
- E-mail: sascha.treskatsch@charite.de
-
Düsseldorf, Alemanha
- Recrutamento
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
-
Contato:
- Sebastian Roth, MD
- Número de telefone: +49 211 81 16253
- E-mail: Sebastian.Roth@med.uni-duesseldorf.de
-
Hamburg, Alemanha
- Recrutamento
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
-
Contato:
- Kristen K Thomsen, MD
- Número de telefone: +4940741070215
- E-mail: kr.thomsen@uke.de
-
München, Alemanha
- Recrutamento
- Department of Anaesthesiology, University Hospital LMU Munich
-
Contato:
- Agnes Meidert, MD
- Número de telefone: +49 89 440081065
- E-mail: Agnes.meidert@med.uni-muenchen.de
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critérios de Inclusão:
Incluiremos pacientes com consentimento ≥45 anos programados para cirurgia eletiva maior não cardíaca sob anestesia geral com monitorização contínua da pressão arterial intra-arterial planejada com cateter arterial radial e com pelo menos dois dos seguintes critérios de risco para desenvolver lesão renal aguda:
- Idade ≥65 anos
- Estado físico ASA III ou IV
- Hipertensão arterial crónica
- Diabetes mellitus que requer medicação
- Cirurgia intra-abdominal
- Insuficiência renal pré-operatória (creatinina sérica ≥1.2 mg/dL)
Critérios de Exclusão:
- Gravidez
- Arritmia cardíaca
- Histórico de hemorragia intracraniana ou aneurisma intracraniano
- Indicação clínica para infusão contínua de norepinefrina durante a indução da anestesia geral (por exemplo, estenose aórtica grave, doença arterial coronária ou insuficiência cardíaca)
- Pacientes que não conseguem compreender, ler e fornecer consentimento informado em alemão
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Administração Contínua de Norepinefrina
Nos doentes designados para administração contínua de norepinefrina, a norepinefrina será administrada continuamente através de uma bomba de perfusão de seringa.
|
Nos doentes designados para administração contínua de noradrenalina, uma bomba de perfusão de seringa será preparada e ligada a um cateter venoso periférico ou central.
O anestesiologista responsável iniciará a perfusão de noradrenalina e ajustará a taxa de perfusão conforme necessário, podendo administrar bolus adicionais de noradrenalina através da bomba de perfusão de seringa, se necessário.
|
|
Sem intervenção: Administração de Norepinefrina em Bolus
Nos pacientes atribuídos à administração manual de noradrenalina em bolus, a noradrenalina será administrada manualmente em doses de bolus.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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.
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Acute kidney injury
Prazo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Nonfatal cardiac arrest
Prazo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Myocardial infarction
Prazo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Death
Prazo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de maio de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
31 de março de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de abril de 2026
Primeira postagem (Real)
20 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-101645-BO-ff
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .