A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of completing clinical and laboratory protocols
研究概览
简要总结
This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.
详细描述
Following informed consent from patient's legally authorized representative, patients will be randomized to hydroxocobalamin or saline. Patients will have blood samples drawn up to 3 hours pre-dose and 3 hours post-dose to measure for hydrogen sulfide levels. Patients will also be followed for 3 hours after study drug infusion to monitor and record vasopressor dependence in norepinephrine-equivalent dose. Patients will then be followed through their medical record for 28 days to determine persistent organ dysfunction syndrome (PODS).
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)
盲法说明
Vitamin B12a is bright red and excreted in the urine. Due to this, patient allocation cannot be masked for patients or individuals who may care for them.
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 at least 18 years of age
- •Admitted to the Medical Intensive Care Unit (MICU) service at Froedtert Hospital
- •Diagnosis of septic shock, as defined by sepsis-3 criteria
排除标准
- •History of calcium oxaluria
研究组 & 干预措施
Saline Placebo
Single IV saline administered over a 10-15 minute period.
干预措施: Placebo (Drug)
Hydroxocobalamin
Single IV infusion administered over a 10-15 minute period
干预措施: Hydroxocobalamin (Drug)
结局指标
主要结局
Feasibility of completing clinical and laboratory protocols
时间窗: 28 days
Feasibility of completing clinical and laboratory protocols
次要结局
- Hydrogen Sulfide Concentration(3 hours)
- Persistent Organ Dysfunction Syndrome (PODS)(28 days)
- Change in vasopressor dose(3, 24, and 48 hours)
- Mortality(28 days)
研究者
Jayshil J. Patel, MD
Associate Professor of Medicine
Medical College of Wisconsin