The Effect of Fluids and Norepinephrine for Mean Arterial Pressure Titration to Patients' Usual Levels on the Microcirculation of Initial Resuscitated Hypertensive Septic Shock Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Perfused vessel density
研究概览
简要总结
Assess the effect of fluids and norepinephrine for mean arterial pressure titration to patients' usual level on the microcirculation of initial resuscitated hypertensive septic shock patients.
详细描述
Microcirculatory dysfunction plays an important role in the development of organ failure in patients with septic shock. Numerous studies focus on the effect of mean arterial pressure (MAP) titration on microcirculation, however, by what strategy is better for microcirculation in septic shock patients with previous hypertension is still a matter of debate. The goal of this study was to assess the effect of different strategies for MAP titration to individualized level on microcirculation in hypertensive septic shock patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients with septic shock for less than 24 hours. Septic shock was defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference.
- •Initial fluid resuscitation was performed to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous hemoglobin saturation for more than 70%.
- •Patients were still requiring NE to maintain the MAP of 65 mm Hg.
排除标准
- •had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm Hg or/and diastolic blood pressure more than 110 mm Hg);
- •were younger than 18 years old or pregnant;
- •were unable to acquire the usual level or resting level of blood pressure;
- •refused to participate the trial.
研究组 & 干预措施
Resp-FL
Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one. The target MAP was maintain MAP within 10% of the reference value.
干预措施: Crystalloid (Drug)
Resp-NE
In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
干预措施: Norepinephrine (Drug)
Nonresp-NE
In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Perfused vessel density
时间窗: 20 minutes
Perfused vessel density of small vessels
次要结局
未报告次要终点
研究者
Jingyuan,Xu
Zhongda Hospital
Southeast University, China