Administración Continua Versus en Bolo de Norepinefrina para Tratar la Hipotensión Postinducción (INDUCT-Multi)
24 de junio de 2026 actualizado por: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
Administración Continua Versus en Bolo de Norepinefrina para Tratar la Hipotensión Postinducción en Pacientes de Cirugía No Cardíaca de Alto Riesgo - El Ensayo Multicéntrico INDUCT (INDUCT-Multi)
INDUCT-Multi es un ensayo aleatorizado multicéntrico que investiga si la administración continua de norepinefrina, en comparación con la administración en bolo, durante la inducción de la anestesia general reduce la hipotensión posterior a la inducción en pacientes de alto riesgo sometidos a cirugía no cardíaca.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
La hipotensión tras la inducción de la anestesia general, conocida como hipotensión postinducción, es frecuente en pacientes sometidos a cirugía no cardíaca y se asocia con lesión renal aguda. Los factores de riesgo de la hipotensión postinducción incluyen edad avanzada, mayor estado físico según la Sociedad Americana de Anestesiólogos, hipertensión arterial crónica y dosis más altas de fármacos anestésicos vasodilatadores. Es razonable suponer que un manejo anestésico cuidadoso puede ayudar a mantener la estabilidad de la presión arterial y limitar la hipotensión postinducción. De acuerdo con esta suposición, la monitorización continua de la presión arterial con un catéter arterial durante la inducción de la anestesia general ayuda a los clínicos a reducir la hipotensión postinducción y, por lo tanto, se recomienda en pacientes de cirugía no cardíaca con riesgo de complicaciones relacionadas con la hipotensión.
Además de la monitorización continua, los anestesiólogos administran rutinariamente vasopresores, como la norepinefrina, para mantener la presión arterial. La norepinefrina es un vasopresor de acción rápida con una vida media corta y suele administrarse como bolos manuales repetidos durante la inducción de la anestesia general. Administrada en bolo, aumenta la presión arterial de manera efectiva y rápida. Sin embargo, los bolos deben repetirse con frecuencia y estar bien sincronizados para garantizar la estabilidad de la presión arterial.
En un ensayo aleatorizado de un solo centro, demostramos que la administración continua, en comparación con el bolo, de norepinefrina durante la inducción de la anestesia general ayuda a mantener la estabilidad de la presión arterial en pacientes de alto riesgo sometidos a cirugía no cardíaca. Ahora nuestro objetivo es probar la hipótesis de que la administración continua, en comparación con el bolo, de norepinefrina durante la inducción de la anestesia general reduce la hipotensión postinducción en pacientes de alto riesgo sometidos a cirugía no cardíaca que tienen monitorización continua de la presión arterial con un catéter arterial.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
446
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kristen K Thomsen, MD
- Número de teléfono: +4940741070215
- Correo electrónico: kr.thomsen@uke.de
Ubicaciones de estudio
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Berlin, Alemania
- Aún no reclutando
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
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Contacto:
- Sascha Treskatsch, MD
- Número de teléfono: +49 30 450 551 522
- Correo electrónico: sascha.treskatsch@charite.de
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Düsseldorf, Alemania
- Reclutamiento
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
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Contacto:
- Sebastian Roth, MD
- Número de teléfono: +49 211 81 16253
- Correo electrónico: Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg, Alemania
- Reclutamiento
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Contacto:
- Kristen K Thomsen, MD
- Número de teléfono: +4940741070215
- Correo electrónico: kr.thomsen@uke.de
-
München, Alemania
- Reclutamiento
- Department of Anaesthesiology, University Hospital LMU Munich
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Contacto:
- Agnes Meidert, MD
- Número de teléfono: +49 89 440081065
- Correo electrónico: Agnes.meidert@med.uni-muenchen.de
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
Incluiremos a pacientes que den su consentimiento, de ≥45 años, programados para cirugía mayor no cardíaca electiva bajo anestesia general con monitorización continua de la presión arterial intraarterial planificada mediante catéter arterial radial y con al menos dos de los siguientes criterios de riesgo para desarrollar lesión renal aguda:
- Edad ≥65 años
- Estado físico ASA III o IV
- Hipertensión arterial crónica
- Diabetes mellitus que requiere medicación
- Cirugía intraabdominal
- Insuficiencia renal preoperatoria (creatinina sérica ≥1,2 mg/dL)
Criterios de exclusión:
- Embarazo
- Arritmia cardíaca
- Antecedentes de hemorragia intracraneal o aneurisma intracraneal
- Indicación clínica para infusión continua de norepinefrina durante la inducción de la anestesia general (por ejemplo, estenosis aórtica grave, enfermedad arterial coronaria o insuficiencia cardíaca)
- Pacientes que no puedan comprender, leer y dar su consentimiento informado en alemán
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Administración Continua de Norepinefrina
En los pacientes asignados a la administración continua de norepinefrina, la norepinefrina se administrará de forma continua mediante una bomba de infusión de jeringa.
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En los pacientes asignados a la administración continua de norepinefrina, se preparará una bomba de infusión de jeringa y se conectará a un catéter venoso periférico o central.
El anestesiólogo responsable iniciará la infusión de norepinefrina y ajustará la velocidad de infusión según sea necesario, y podrá administrar bolos adicionales de norepinefrina a través de la bomba de infusión de jeringa si es necesario.
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Sin intervención: Administración de Norepinefrina en Bolo
En los pacientes asignados a la administración manual de norepinefrina en bolo, la norepinefrina se administrará manualmente en dosis en bolo.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Periodo de tiempo: 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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
Periodo de tiempo: 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.
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Area under a MAP of 50 mmHg (mmHg x min)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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.
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Area above a MAP of 110 mmHg (mmHg x min)
Periodo de tiempo: 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.
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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.
|
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Area above a MAP of 120 mmHg (mmHg x min)
Periodo de tiempo: 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.
|
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Area above a MAP of 140 mmHg (mmHg x min)
Periodo de tiempo: 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.
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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.
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Duration of a MAP <65 mmHg (min)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
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Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Acute kidney injury
Periodo de tiempo: Within the first 3 postoperative days
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Within the first 3 postoperative days
|
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Nonfatal cardiac arrest
Periodo de tiempo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Myocardial infarction
Periodo de tiempo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Death
Periodo de tiempo: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
31 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de abril de 2026
Publicado por primera vez (Actual)
20 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-101645-BO-ff
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .