Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
To compare different goals of fluid resuscitation in early stage of acute pancreatitis
详细描述
With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
- •Onset of abdominal pain within <=72h before admission
- •moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012
- •Evidence of >= 1 predictor of fluid resuscitation: Haematocrit >44% (male) or >40% (female), respectively Lactate>4mmol/L; heart rate>120bpm; urine <0.5ml/kg/h for 6 hour; Mean arterial pressure>85 or <60 mmHg
排除标准
- •New York Heart Association classification >II
- •With pacemaker implantation
- •chronic obstructive pulmonary disease
- •chronic kidney disease
- •Pre-existing disease with life expectancy < 3 months
研究组 & 干预措施
Goal A
controled fluid therapy: 5~10ml/kg/hr fulfillment of two or more of four criteria:
- heart rate <120 beats/min,
- mean arterial blood pressure 65-85 mm Hg,
- urine output ≥1 ml/kg /h
- Hematocrit ≤35%.
干预措施: Goal A (Other)
Goal B
controled fluid therapy: 5~10ml/kg/hr fulfillment of all of the following criteria:
1 central venous pressure8-12 mmHg , 2.mean arterial pressure 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%
干预措施: Goal B (Other)
结局指标
主要结局
Mortality
时间窗: 28day
次要结局
- intra-abdominal Hypertension(7 days)