Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time to shock reversal
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
详细描述
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.
In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years old or older;
- •diagnosis of septic shock within 12 h.
排除标准
- •recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
- •definitive pulmonary hypertension or chronic pulmonary heart disease;
- •known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
- •known allergy to methylene blue, phenothiazines, or food dyes;
- •anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
- •refusal of the attending staff or patient family;
- •participated in other study.
研究组 & 干预措施
Methylene Blue
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first).
干预措施: Methylene Blue (Drug)
Placebo
5% dextrose solution in a volume to match experimental arm component.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to shock reversal
时间窗: 90 days after randomization
Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h.
次要结局
- 28-day mortality(28 days after randomization)
- ICU mortality(90 days after randomization)
- 90-day mortality(90 days after randomization)
- Hospital mortality(90 days after randomization)
研究者
Qing-quan Lv
Principal Investigator
Northern Jiangsu People's Hospital