Renin and Renal Biomarker Response to Angiotensin II Versus Controls in Septic Shock: An Open-Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Plasma Renin Levels
研究概览
简要总结
Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Medical ICU admission
- •Septic shock
- •Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)
- •Kidney Disease Improving Global Outcomes stage 1 or greater AKI
排除标准
- •Pregnancy
- •Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree
- •Purely cardiogenic shock (no distributive component)
- •Mesenteric ischemia
- •Acute ischemic stroke
- •Hemorrhagic shock
- •Active treatment of hepatorenal syndrome targeting a MAP = 65 mm Hg
- •Planned withdrawal of care within next 24 hours or no escalation of care
- •Patient enrolled in an interventional study
- •High likelihood of medical futility in using this drug:
- •3 or more vasopressors required to sustain MAP
- •Sustained norepinephrine equivalents > 0.5 mcg/kg/min
- •COVID-19 positive, or high suspicion of COVID-19
研究组 & 干预措施
Standard of Care Cohort
Patients in this group will receive standard of care treatment.
干预措施: Standard of Care (Other)
Angiotensin II Cohort
Patients in this group will receive angiotensin II.
干预措施: Angiotensin II (Drug)
结局指标
主要结局
Change in Plasma Renin Levels
时间窗: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)
Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.
次要结局
- Change in Plasma Cystatin C(Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days))
- Days to Discontinuation of Catecholamines(Until shock resolution, up to 14 days)
- ICU Length of Stay(From enrollment to ICU discharge, up to 28 days following enrollment)
- Number of Participants With In-hospital Mortality(Up to 3 months following enrollment)
- Renal Replacement Therapy-free Days(Within 28 days of enrollment)
- Number of Participants Experiencing Prespecified Safety Outcomes(Up to 72 hours following shock resolution, no longer than 17 days from enrollment)
- Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL)(Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days))
研究者
Alexander Flannery
Assistant Professor
University of Kentucky