The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 28days-Mortality in ICU
研究概览
简要总结
Patients with septic shock with norepinephrine >0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.
Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).
Extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. The time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study.
The data were monitored according to the time points specified in the study: baseline,0h , 6h, D1, D2, and post-drug withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Septic shock patients with norepinephrine>0.25ug/kg/min
排除标准
- •Under 18 years of age
- •Acute coronary syndrome requiring treatment
- •have been treated with VA-ECMO
- •VV-ECMO treatment has been administered for less than 12 hours
- •Patient is on posterior pituitary hormone
- •Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 30
- •Patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose
- •absolute neutrophil counts below 1,000/mm3
- •Patients with active bleeding who are expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate patients with active bleeding that is expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate
- •malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
- •Confirmed or suspected acute mesenteric ischemia. If the investigator believes that the patient's condition is highly suspicious but not confirmed by conventional criteria The investigator may exclude a patient if, in the opinion of the investigator, the patient's condition is highly suspicious but not confirmed by conventional criteria, or if the treating physician has initiated empiric therapy.
- •Likely death expected within 12 hours
- •Family or physician plans to implement a palliative care plan for the patient
研究组 & 干预措施
norepinephrine+vasopressin
norepinephrine+vasopressin
干预措施: norepinephrine+vasopressin (Drug)
Norepinephrine
norepinephrine
干预措施: Norepinephrine (Drug)
结局指标
主要结局
28days-Mortality in ICU
时间窗: 28 days
28 day mortality rate
ICU duration
时间窗: an average of 1 year
Residence time in ICU
次要结局
- RVDEA/LVDEA(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- right ventricular thickness(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- Tricuspid Annular Plane Systolic Excursion(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- Intestinal ultrasound score(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- pulsatility index of the middle cerebral artery(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- resistance index of superior mesenteric artery(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))
- venous excess ultrasound grading system(VexUS)(baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week))