Evaluation of Early Methylene Blue in the Microhemodynamics of Septic Shock Patients: a Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility of the study protocol.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the high probability of the intervention group present blue coloured skin and secretions caused by MB infusion, the study is classified as open-label for patients, assisting staff and investigators. Blinding remains for the team that will perform the statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with septic shock according to SEPSIS-3 definition, within less than 6 hours of the diagnosis.
排除标准
- •Pregnant or breastfeeding patients;
- •Patients with any withdrawal or withholding life-sustaining intervention;
- •Cardiac surgery patients in the immediate postoperative period;
- •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.
研究组 & 干预措施
Methylene blue group
The intervention group will receive methylene blue plus standard treatment for septic shock, according to the international guidelines.
干预措施: Methylene blue infusion (Drug)
结局指标
主要结局
To evaluate the feasibility of the study protocol.
时间窗: 28 days after randomization.
The primary outcome of the study is to evaluate feasibility, defined as completing the study protocol according to the planned timeline and with 90% or more protocol adherence. Protocol adherence will be defined as the use of the allocated therapy in the intervention group for 6 hours for 3 days (or interruption of methylene blue if the patient does not require a vasoactive drug anymore). Justified interruptions will not be considered violations.
次要结局
- Capillary refill time(72 hours after randomization.)
- Serum lactate level(72 hours after randomization.)
- Arteriovenous carbon dioxide difference (gapCO2)(72h after randomization.)
- Central venous oxygen saturation (SvO2)(72h after randomization.)
- Serial measurements of heart rate(72 hours after randomization.)
- Serial measurements of mean arterial pressure(72 hours after randomization.)
- Serial measurements of pulse pressure(72 hours after randomization.)
- Serial measurements of systolic arterial pressure(72 hours after randomization.)
- Serial measurements of dyastolic arterial pressure(72 hours after randomization.)
- Methylene blue-related adverse events(28 days after randomization.)
研究者
Bruna Cassia Dal Vesco
Clinical Research Fellow
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva