A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Mean Arterial Pressure
研究概览
简要总结
The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.
详细描述
If subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. Subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (ICU) care afterwards. Kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. Study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Masking and blinding will be carried out by the research pharmacy with unmasking to be performed at study completion through the research pharmacy and statistician.
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
- •Any patient for whom we are able to obtain consent ahead of their procedure
- •Patients presenting for a procedure in which cardiopulmonary bypass will be required
- •Considered high risk for vasoplegic syndrome
- •Has no contraindications to arterial line or PA catheter placement
- •Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.
排除标准
- •Age<18 years
- •Known pregnancy or patients without a documented pregnancy test if not menopausal.
- •Known prior anaphylactic or allergic reaction to B12a
- •CKD stage 4 or worse
- •ECMO (extracorporeal membrane oxygenation) prior to study consent.
- •Patients currently on cardiopulmonary bypass
研究组 & 干预措施
B12a
Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
干预措施: Hydroxocobalamin (Drug)
B12a
Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
干预措施: Cardiopulmonary Bypass (Procedure)
Placebo
Subjects will receive placebo
干预措施: Cardiopulmonary Bypass (Procedure)
Placebo
Subjects will receive placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Change in Mean Arterial Pressure
时间窗: baseline, 4 hours
The average pressure in a patient's arteries during one cardiac cycle
次要结局
- Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol(baseline, 4 hours)
- Change in Systolic Blood Pressure(baseline, 4 hours)
- Death(30 days)
- Duration of Hospital Stay(30 days)
- Duration of Intensive Care Stay(30 days)
研究者
James A. Nelson
Principle Investigator
Mayo Clinic