Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α)
研究概览
简要总结
The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock.
The main questions it aims to answer are:
- Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
- Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
- Are measurements of blood oxygen in tissues just below the skin different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures and measurements of oxygen in tissues from a sensor placed on one of the hands will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one blood sample. At the time the sample is collected, advanced echocardiography pictures and measurements of oxygen in tissues from a sensor placed on one of the hands will be taken. This research also involves analyzing data obtained during the participant's hospital stay.
详细描述
Septic shock mortality remains high at 33% in North America; current clinical predictors of poor outcomes in septic shock are suboptimal. In addition to antibiotics and intravenous fluids, vasoactive agents are initiated to restore effective tissue perfusion. Norepinephrine (NE) is the recommended first-line vasopressor, but adjunctive arginine vasopressin is used in over one-third of patients to improve blood pressure or decrease NE dosage. However, less than half of vasopressin recipients have a clinically-apparent hemodynamic response (defined as a decrease in NE dosage at 6 hours after vasopressin initiation). Vasopressors, particularly norepinephrine, are known to be immune modulators. Further, each vasopressor has its own unique effect on a patient's hemodynamic profile as assessed by echocardiography and microcirculation measurements. In the current study, the investigators seek to clarify the link between vasopressin, immune response, hemodynamic profile, and microcirculatory measurments. The central goal of this proposal is to identify "vasopressin response" as an easily-identifiable bedside indicator of a distinct septic shock subphenotype.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (≥18 years old)
- •Septic shock (as defined by Sepsis-3)
- •Receiving norepinephrine
- •Admitted to a medical, surgical, NeuroSciences, or mixed intensive care unit
- •Central venous catheter in place
- •Ordered fixed-dose vasopressin as an adjunct to norepinephrine by the primary care team (unless in active control cohort)
排除标准
- •Vasopressin ordered for an indication other than septic shock
- •Vasopressin initiated at another institution
- •Receiving a primary vasopressor other than norepinephrine (eg, phenylephrine)
- •Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the preceding 28 days
- •Blood hemoglobin concentration <7 g/dL
- •Primary treatment team determines that vasopressin initiation is emergent
- •Patient or their legal authorized representative opts to not participate in the study
研究组 & 干预措施
Vasopressin plus norepinephrine
Patients with septic shock ordered vasopressin as an adjunct to norepinephrine
干预措施: Vasopressin (Drug)
Norepinephrine
Active control cohort of patients with septic shock who are only receiving norepinephrine
结局指标
主要结局
Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α)
时间窗: Baseline (before vasopressin initiation and within 45 minutes of order placement).
Compare baseline ratio of plasma concentrations of interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis.
次要结局
- Left ventricular ejection fraction (LVEF)(Baseline (before vasopressin initiation and within 45 minutes of order placement).)
- Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees)(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- Lipopolysaccharide-stimulated monocyte TNF-α secretion(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- Monocyte adhesion(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- Plasma renin concentration(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- Plasma angiopoietin-2 concentration(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- StO2 recovery slope (%/min)(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
- Difference in StO2 (%)(Baseline (before vasopressin initiation and within 45 minutes of order placement) through one to six hours after vasopressin initiation.)
研究者
Seth Bauer
Principal Investigator
The Cleveland Clinic