Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Continuous Norepinephrine Administration.
- Кому может быть актуально
- Состояния в реестре: Postinduction Hypotension. Базовые параметры: от 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
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Официальное название
Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension in High-Risk Non-Cardiac Surgery Patients - The Multicenter INDUCT Trial (INDUCT-Multi)
Обзор
INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.
Подробное описание
Hypotension after induction of general anesthesia, referred to as postinduction hypotension, is common in patients having non-cardiac surgery and is associated with acute kidney injury. Risk factors for postinduction hypotension include older age, higher American Society of Anesthesiologists physical status, chronic arterial hypertension - and higher doses of vasodilating anesthetic drugs. It is reasonable to assume that careful anesthetic management can help maintain blood pressure stability and limit postinduction hypotension. Consistent with this assumption, continuous blood pressure monitoring with an arterial catheter during induction of general anesthesia helps clinicians reduce postinduction hypotension - and is thus recommended in non-cardiac surgery patients at risk for hypotension-related complications.
Besides continuous monitoring, anesthesiologists routinely give vasopressors - such as norepinephrine - to maintain blood pressure. Norepinephrine is a fast acting vasopressor with a short half-life and is usually given as repeated manual boluses during induction of general anesthesia. Given as a bolus, it effectively and rapidly increases blood pressure. However, boluses need to be frequently repeated and well-timed to ensure blood pressure stability.
In a single-center randomized trial, we demonstrated that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia helps maintain blood pressure stability in high-risk non cardiac surgery patients. We now aim to test the hypothesis that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients who have continuous blood pressure monitoring with an arterial catheter.
Вмешательства
- Процедура Continuous Norepinephrine Administration
In patients assigned to continuous administration of norepinephrine, a syringe infusion pump will be prepared and connected to a peripheral or central venous catheter. The responsible anesthesiologist will start the norepinephrine infusion and adjust the infusion rate as necessary and may administer additional norepinephrine boluses via the syringe infusion pump if required.
Первичные конечные точки
- Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) [Срок оценки: 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.]
Вторичные конечные точки (12)
- Area under a MAP of 60 mmHg (mmHg x min) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]
Критерии участия
Критерии включения
We will include consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury:
- Age ≥65 years
- ASA physical status III or IV
- Chronic arterial hypertension
- Diabetes mellitus requiring medication
- Intra-abdominal surgery
- Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)
Критерии исключения
- Pregnancy
- Cardiac arrhythmia
- History of intracranial hemorrhage or intracranial aneurysm
- Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure)
- Patients who are unable to understand, read, and provide informed consent in German
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Германия · 4 центра
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charit — Berlin
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University D — Düsseldorf
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, Univer — Hamburg
- Department of Anaesthesiology, University Hospital LMU Munich — München
Идентификаторы
NCT: NCT07538388 · 2025-101645-BO-ff