Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in mean arterial pressure
研究概览
简要总结
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.
详细描述
The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor. The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).
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
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
- •Meets Sepsis-3 Criteria (Suspected source of infection plus any 2 criteria of the qSOFA)
- •2 .Septic Shock (any patient requiring vasopressor therapy to maintain MAP >65 mmHg or any patient with serum lactate >2 mmol/dL even in the absence of hypovolemia ).
- •Greater than 18 years old
- •4 ) ICU Admission
排除标准
- •Inability to obtain informed consent from an appropriate surrogate decision maker.
- •Children less than 18 years old
- •Pregnant women or positive urinary pregnancy test in reproductive-aged women
- •Evolving myocardial infarction or known cardiomyopathy with documented EF<35%
- •Known grade 3 diastolic dysfunction document by echocardiogram
- •Known hypersensitivity to thiazine dyes
- •Pulmonary hypertension that is currently requiring vasodilator therapy
- •Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
- •Known documented history of G6PD deficiency or favism
- •Active prior to admission medication prescription for a SSRI or SNRI , systemic heparin anticoagulation or other medications listed above (under Study Agent). These medications will be listed in the printed enrollment form.
- •Severe renal failure is a contraindication to use of ProvayBlue®.
研究组 & 干预措施
Control group
Patients in the control group will have phenylephrine infusion starting at 50 mcg/min and titrated to maintain a MAP >65 mmHg as a third line vasopressor. Maximum dose of Phenylephrine is 300 mcg/min.
干预措施: Phenylephrine (Drug)
Intervention group
Patients enrolled in the intervention group will receive 2 mg/kg IBW (Ideal Body Weight) bolus, given over 15 mins, of ProvayBlue® followed by a concomitant infusion at 2 mg/kg/hr (IBW) mixed in D5W, which will continue for 24 hours. ProvayBlue® ( Methylene Blue) will be used as the third-line vasopressor.
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Change in mean arterial pressure
时间窗: One hour and 24 hours after dose
The primary objective is to determine if the administration of ProvayBlue® is non-inferior to the use of phenylephrine as a third-line vasopressor to keep a mean arterial pressure (MAP)\>65 mmhg after one hour and at 24 hours after the initiation of the drugs.
次要结局
- Incidence of acute kidney injury requiring dialysis(through time of patient discharge, an average of 8 days after admission)