Prospective, Randomized, Controlled Trial Assessing the Effects of Methylene Blue for the Prevention of Hypotension During Renal Replacement Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Composite Endpoint
研究概览
简要总结
Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients.
This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.
详细描述
BLUE is a randomized, multicenter, open-label trial. Patients with high risk of hypotension during RRT will be randomized to receive either methylene blue infusion at a dose of 1 mg/kg as a bolus, followed by continuous infusion of 0.1 mg/kg of body weight in a total of 200 mL of saline solution throughout the dialysis session, or to usual care. The usual care group will not receive any intervention. A total of 260 patients are expected to be randomized in a 1:1 ratio.
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
- None
盲法说明
Blinding of healthcare professionals is not feasible due to the distinct visual of methylene blue. However, outcome assessors and statisticians will remain blinded to group allocation to minimize bias.
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
- •Patients over 18 years old
- •Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renal replacement therapy hemodialysis
- •Systolic blood pressure lower than 100 mmHg or use of vasopressor
- •Signed informed consent
排除标准
- •Pregnancy
- •Life expectancy less than 24 hours
- •Exclusive palliative or end-of-life care
- •RRT due to hypertensive crisis
- •Known allergy to methylene blue
- •Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Prior participation in the study
- •Acute coronary syndrome
- •Chronic nitrate oral use
研究组 & 干预措施
Control
usual care
干预措施: Control (Other)
Methylene Blue
Methylene blue will be infused during renal replacement therapy
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Composite Endpoint
时间窗: 6 hours
The primary outcome will be a composite consisting of any of the following events: (1) initiation of vasopressor therapy or an increase in vasopressor dose by at least 20% from baseline; (2) interruption of the RRT session; (3) interruption of fluid removal at the request of the attending physician at any point during the session.
次要结局
- Mortality in the hospital(60 days)
- Mortality in the intensive care unit(60 days)
- Hypotension(6 hours)
- Maximum vasopressor dose(24 hours)
- Norepinephrine equivalent dose (NEE)(24 hours)
- RRT session fluid balance(24 hours)
- 24-hour fluid balance(24 hours)
研究者
Flavia Ribeiro Machado
Chief of Critical Care Department
Federal University of São Paulo