Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
研究概览
简要总结
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Suspected or documented infection
- •Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
- •Serum lactate levels >2 mmol/L
- •Norepinephrine infusion of > 0.2 mcg/kg/min
排除标准
- •Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
- •Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
- •Lithium treatment
- •Treatment with other vasopressor or inotropic drugs.
研究组 & 干预措施
Septic Shock
Adult patients with septic shock, admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively. Sedated and mechanically ventilated adult patients (>18 years).
干预措施: Hemodynamic measurements during reduction in Norepinephrine and fluid boli. (Drug)
结局指标
主要结局
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
时间窗: Through study completion, an average of 1 year
The number of patients who were preload responsive after down-titration of NE.
次要结局
- CO measurement method(Through study completion, an average of 1 year)
- Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.(Through study completion, an average of 1 year)
- Microcirculation/perfusion measures during intervention.(Through study completion, an average of 1 year)
研究者
Henrik Wolsted
Doctor
Copenhagen University Hospital, Hvidovre