An Open-label, Single-arm, Single-center Study Evaluating the Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II
研究概览
简要总结
Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy.
The current literature suggests that earlier initiation of angiotensin-II will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. In addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. The purpose of this study is to evaluate the efficacy of angiotensin-II when used as the second vasopressor agent for septic shock.
详细描述
Objectives:
Primary Objective:
- To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock
Secondary Objectives:
- To assess the duration of response to ang-II
- To assess overall survival
- To assess the amount of time spent in the ICU
- To assess the need for renal replacement therapy
- To assess the overall duration of vasoactive medication use
- To assess toxicity and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure <65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate >2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature >100.4°F or <96.8°F; heart rate >90/min; respiratory rate >20/min and a white blood cell count >12,000/mm3 or <4,000/mm3.
排除标准
- •Age <18 years
- •Pregnancy or lactation
- •Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
- •Requiring >25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
- •Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
- •Treatment with another investigational drug or other intervention during study timeframe
研究组 & 干预措施
Single Arm
Drug: Angiotensin II Other Names: Giapreza
干预措施: Angiotensin II and hydrocortisone sodium succinate (Drug)
结局指标
主要结局
The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II
时间窗: 1 hour
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II.
次要结局
- The incidence of hemodynamic response at 3 hours after initiation of angiotensin-II(3 hours)
- Vasoactive medication duration overall(1 year)
- The incidence of hemodynamic response at 6 hours after initiation of angiotensin-II(6 hours)
- 28-day mortality(28 days)
- ICU length of stay(1 year)
- Need for renal replacement therapy(1 year)
- Incidence of adverse reactions(1 year)
研究者
Tyson Dietrich
Pharmacist
Kingman Regional Medical Center