Controlled Fluid Resuscitation Strategy in Sepsis Patient
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 主要终点
- Mortality
研究概览
简要总结
To evaluate two different strategy of fluid resuscitation in sepsis patients
详细描述
Early goal-directed fluid therapy (EGDT) had been regarded as an important fluid therapy strategy in early sepsis or septic shock patients. In recent years, several randomized control studies showed the EGDT therapy cannot make a better outcome in sepsis patients compared to the standard therapy. A strategy of controlled fluid resuscitation had showed good outcome in critical illness such as severe acute pancreatitis, major trauma. But many aspects of the so-called controlled fluid resuscitation remained controversial. In a previous study on severe acute pancreatitis, we described a bundle of controlled fluid resuscitation which had showed an ideal result with higher survival rate. So, we are going to use the bundle on sepsis patients, and to see if it can bring a better out come in sepsis patients compared to the EGDT strategy. This study aims to determine a better strategy of fluid resuscitation in sepsis 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 (Participant)
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.sepsis patients in accordance with the Sepsis 3.0 definition(SOFA increase ≥2 compared to the baseline，due to infection )
- •2.the first blood lactate in our hospital is ≥ 4mmol/L or MAP<90mmHg after 20ml/kg fluid bolus
- •3.the shock is diagnosed within 24hrs after onset
排除标准
- •- 1.<18 years old
- •2.Pregnancy
- •3 with co-morbidity such as AE-COPD, stroke, seizure, lung edema, acute coronary syndrome
- •4 with contra-indication of CVC(central venous catheter) placement
- •5 trauma or major burn
- •6 poisoning
- •7 any cancer receiving chemotherapy
- •8.immunosuppression (for organ transplantation or disease of immune system)
- •9.acute pancreatitis
- •10.relapse sepsis
研究组 & 干预措施
EGDT Group
Early Goal Directed Therapy ：30ml/kg in the first bolus to have a CVP（central venous pressure） 8-12 mmHg and MAP（mean artery pressure ） 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%；If not, use noradrenaline，red blood cell transfusion if necessary.
干预措施: Early Goal Directed Therapy (Other)
Ruijin Group
Ruijin Strategy therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary.
target： fulfillment of two or more of four criteria:1. HR（heart rate） <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT（hematocrit） 25%~35%.
干预措施: Ruijin Strategy (Other)
结局指标
主要结局
Mortality
时间窗: the 28th day from enrolled
Mortality
次要结局
- Mortality(the 60th day from enrolled)