ANGIOtensin II for Septic Shock in the Emergency Department: ANGIO-ED Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of completing all clinical trial activities
研究概览
简要总结
This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED
详细描述
Following informed consent, patients will receive intravenous angiotensin II (AT-II) infusion for blood pressure support. The patient will remain on the AT-II infusion for 60 minutes prior to determining patient response which will be determined by recording the concurrent dose of norepinephrine and MAP every 10 minutes from initiation. If a positive response (e.g., norepinephrine dose reduction) is witnessed, the AT-II infusion will be titrated off after a maximum of 6 hours or when infusion is completed, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18; and
- •Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min mcg/kg/minute despite adequate fluid resuscitation; and
- •Receiving intravenous antibiotics or clinician's intention to administer antibiotics at the time of enrollment; and
- •Can provide written informed consent (or legally authorized representative).
排除标准
- •Acute coronary syndrome;
- •Cardiogenic shock;
- •Patients with a history of mesenteric ischemia;
- •Patients with a history of having an aortic dissection or abdominal aortic aneurysm;
- •Patients with an expected lifespan of <12 hours;
- •Patients with hemorrhagic shock (e.g., actively receiving transfusion of packed red blood cells);
- •Active administration of two vasoactive agents before enrollment; and
- •Pre-existing thromboembolic disease or inability to tolerate pharmacologic VTE prophylaxis.
研究组 & 干预措施
Angiotensin II Infusion
干预措施: Angiotensin II Infusion (Drug)
结局指标
主要结局
Feasibility of completing all clinical trial activities
时间窗: From enrollment to the end of treatment up to 6 hours after the angiotensin II infusion is initiated
Percentage of patients who provide informed consent and receive angiotensin II infusion in the emergency department
次要结局
- Mean arterial pressure response(60 minutes after the intiation of angiotensin II infusion)
- Mean norepinephrine dose (during angiotensin II infusion)(60 minutes after the intiation of angiotensin II infusion)
- Mean norepinephrine dose (post angiotensin II infusion)(60 minutes after the completion of the angiotensin II infusion)
研究者
Brett A Faine
Clinical Associate Professor
University of Iowa