The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Systemic Vascular Resistance (SVR)
研究概览
简要总结
This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cyanokit
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
干预措施: Hydroxocobalamin (Drug)
Methylene Blue
Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Systemic Vascular Resistance (SVR)
时间窗: 15, 30, 60, 90 and 120 minutes after initiation of treatment
SVR refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Diastolic Blood Pressure
时间窗: 15, 30, 60, 90 and 120 minutes after initiation of treatment
Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Vasopressin
时间窗: 15, 30, 60, 90 and 120 minutes after initiation of treatment
Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Systolic Blood Pressure
时间窗: 15, 30, 60, 90 and 120 minutes after initiation of treatment
Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
次要结局
- Post-operative Intensive Care Unit (ICU) Length of Stay(Up to 30 days after surgery)
- Post-operative Complications(Up to 30 days after surgery)
- Hospital Length of Stay(Up to 30 days after surgery)
研究者
Sher-Lu Pai
Consultant in Anesthesia
Mayo Clinic