Vasopressin for Septic Shock Pragmatic Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,959
- 试验地点
- 26
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
Life-threatening low blood pressure due to a serious infection is called "septic shock." Septic shock is treated with vasopressors, medications that raise blood pressure. Sometimes first-line vasopressors are inadequate, prompting addition of a second-line vasopressor called vasopressin. However, the threshold at which to start vasopressin remains unclear. This pragmatic, cluster-randomized, cluster-crossover trial will evaluate two different strategies for septic shock treatment commonly used in current practice, comparing a lower versus a higher threshold for adding vasopressin to first-line vasopressors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years
- •Admitted to a study hospital emergency department (ED) or inpatient care unit
- •Administration of vasopressor(s) for septic shock
排除标准
- 未提供
研究组 & 干预措施
Septic shock treatment strategy involving a lower threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.1 micrograms/kilogram/minute (mcg/kg/min). Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
干预措施: Vasopressin (Drug)
Septic shock treatment strategy involving a higher threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.4 mcg/kg/min. Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
干预措施: Vasopressin (Drug)
Septic shock treatment strategy involving a lower threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.1 micrograms/kilogram/minute (mcg/kg/min). Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
干预措施: Recommendation to use a lower initiation threshold for vasopressin (Other)
Septic shock treatment strategy involving a higher threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.4 mcg/kg/min. Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
干预措施: Recommendation to use a higher initiation threshold for vasopressin (Other)
结局指标
主要结局
28-day all-cause mortality
时间窗: 28 days
Death on or before study day 28
次要结局
- Renal replacement therapy-free days to day 28(28 days)