Early Methylene Blue in the Microhemodynamics of Septic Patients
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: Methylene blue infusion.
- Кому может быть актуально
- Состояния в реестре: Septic Shock, Hypoperfusion. Базовые параметры: от 18 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
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Early Methylene Blue in the Microhemodynamics of Septic Patients: a Feasibility Randomized Controlled Trial
Обзор
The aim of the study is to evaluate the viability and feasibility of its protocol in order to conduct a larger clinical trial to assess whether methylene blue can improve patient-centered clinical outcomes such as mortality or length of hospital stay in septic shock patients.
Подробное описание
One of the primary causes of high mortality in patients with septic shock is microcirculatory dysfunction related to vasodilation caused by excessive oxide nitric production. It has been shown that methylene blue, an old and safe drug that can reduce vasodilation by blocking nitric oxide pathways, is a vasopressor-sparing treatment in sepsis. Nevertheless, there is no evidence that methylene blue improves patient-centered clinical outcomes such as mortality. Understanding how early methylene blue affects the microhemodynamics of septic shock patients may lead to relevant clinical results that can improve their prognosis. So, the objective of the study is to evaluate the viability and feasibility of the study protocol for a larger clinical trial, assessing the effectiveness of early methylene blue in the microhemodynamics of septic shock patients, mainly through the capillary refill time measurement. For this purpose, a pilot study of an open-label, randomized, controlled and single-center clinical trial will be conducted, with two treatment arms: the intervention group (methylene blue plus standard treatment) and the control group (standard treatment). Fifty adult patients with septic shock within the first six hours of diagnosis will be included in this study. They will be randomized to either receive a methylene blue infusion or not. The randomization will be conducted using RedCap with a 1:1 ratio and variable block sizes. The primary outcome will be to assess the feasibility, which is defined as completing the study recruitment within the 12-month timeline and achieving protocol adherence of 90% or higher. Comparisons between groups for serially measured micro and macrohemodynamics parameters will be the secondary outcomes. Additionally, the incidence of adverse events related to methylene blue will be monitored.
Вмешательства
- Препарат Methylene blue infusion
Methylene blue at a dose of 100mg (diluted in 100ml of 5% dextrose solution) in continuous infusion for 06 hours per day, for 03 days, plus standard treatment according to international guidelines for the management of sepsis and septic shock. The 03 consecutive MB infusions, each lasting 06 hours, will be performed every 24 hours, starting from randomization: the first infusion at T0, the second at T24, and the third at T48, considering T0 the moment after the patient randomization into the stu
Первичные конечные точки
- To evaluate the feasibility of the study protocol. [Срок оценки: 28 days after randomization.]
Вторичные конечные точки (10)
- Capillary refill time [Срок оценки: 72 hours after randomization.]
- Serum lactate level [Срок оценки: 72 hours after randomization.]
- Arteriovenous carbon dioxide difference (gapCO2) [Срок оценки: 72h after randomization.]
- Central venous oxygen saturation (SvO2) [Срок оценки: 72h after randomization.]
- Serial measurements of heart rate [Срок оценки: 72 hours after randomization.]
- Serial measurements of mean arterial pressure [Срок оценки: 72 hours after randomization.]
- Serial measurements of pulse pressure [Срок оценки: 72 hours after randomization.]
- Serial measurements of systolic arterial pressure [Срок оценки: 72 hours after randomization.]
- Serial measurements of dyastolic arterial pressure [Срок оценки: 72 hours after randomization.]
- Methylene blue-related adverse events [Срок оценки: 28 days after randomization.]
Критерии участия
Критерии включения
- Adult patients with a diagnosis of sepsis and persistent hemodynamic dysfunction despite adequate fluid resuscitation, requiring escalation of noradrenaline dose to maintain mean arterial pressure ≥65 mmHg, with prolonged capillary refill time or septic shock according to Sepsis-3 definition, within less than 6 hours of the diagnosis, will be eligible for the study.
Критерии исключения
- Pregnant or breastfeeding patients;
- Patients with any withdrawal or withholding life-sustaining intervention;
- Cardiac surgery patients in the immediate postoperative period;
- Refractory septic shock, with a high propability of death within 24 hours;
- Personal or familiar history of glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- Allergy to methylene blue, phenothiazines, or food dyes;
- Recent administration of linezolid (less than 14 days ago);
- Recent intake of serotonergic psychiatric medications (less than 2 weeks ago - with the exception of fluoxetine, which must be less than 5 weeks ago),
- Recent intake (less than 2 weeks ago) of monoamine oxidase inhibitors (MAOIs), such as rasagiline and selegiline.
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Бразилия · 1 центр
- Irmandade da Santa Casa de Misericórdia de Curitiba — Curitiba
Идентификаторы
NCT: NCT07264543 · U1111-1331-7627 · Approval number 7.955.174 · CAAE 93099325.5.0000.0020