Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- 28-day survival rate of enrolled patients
研究概览
简要总结
The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock, shorten the duration of norepinephrine use, reduce the dosage of vasopressors, promptly correct hemodynamics, and improve tissue perfusion and organ function impairment.
详细描述
Researchers will compare methylene blue to a placebo (a look-alike substance that contains no drug) to see if methylene blue works to treat severe septic shock.
Participants will:
Administer a loading dose of 2.5 mg/kg via micro-pump over 15 minutes, followed by a maintenance infusion at a rate of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first. If norepinephrine needs to be increased to 0.25 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.
Primary Study Endpoint
- 28-day all-cause mortality rate starting from the diagnosis of septic shock.
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
This study implements blinding for the outcome assessor.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Meets the Sepsis 3.0 criteria for septic shock: patients with infection who, despite adequate fluid resuscitation, require vasopressor therapy to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg and have a blood lactate concentration > 2 mmol/L.
- •Diagnosed with septic shock and started on norepinephrine within 24 hours.
- •Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.
排除标准
- •Pregnant or breastfeeding women.
- •Individuals allergic to methylene blue or any components of the methylene blue injection.
- •Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •Patients with an expected survival time of less than 48 hours.
- •Patients who have been on norepinephrine for more than 24 hours.
研究组 & 干预措施
Methylene Blue Intervention Group
Methylene blue injection, 2.5 mg/kg loading dose over 15 minutes, followed by a continuous infusion of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first.
干预措施: Methylene Blue Intervention Group (Drug)
Normal Saline Control Group
Normal saline solution, administered in the same manner and duration as the methylene blue intervention.
干预措施: Normal Saline Control Group (Drug)
结局指标
主要结局
28-day survival rate of enrolled patients
时间窗: 28-day
Our primary endpoint is the 28-day survival rate of enrolled patients: All enrolled patients will be followed from the time of randomization until 28 days post-enrollment, recording the survival status on the 28th day after enrollment. If a patient dies within 28 days post-enrollment, the number of survival days will be recorded. Note: 1. Cases where the family requests discharge to home for end-of-life care and the patient subsequently dies will be counted as death cases. 2. Cases where the family requests discharge for non-medical reasons such as financial constraints and no further treatment is sought will be counted as dropout cases.
次要结局
- The duration and dosage of norepinephrine use(28-day)
- The duration of mechanical ventilation(28-day)
- The duration of overall hospital stay(28-day)
- The duration of ICU stay(28-day)
- The safety of methylene blue injection(28-day)