Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
研究概览
简要总结
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.
This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).
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
- None
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
- •Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg
排除标准
- •Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
- •Cirrhosis patients in septic shock with structural heart disease
- •Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
- •Cirrhosis patients in shock, caused by other reasons, other than septic shock
- •Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
- •Age less than 18 years
- •Previous episode of septic shock during the same hospital stay
- •Pregnant or lactating women
- •Patients in need for emergent surgical interventions
- •Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
- •Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products
- •A previous adverse reaction to human albumin solution
研究组 & 干预措施
5% albumin Infusion
(250 ml over 15 to 30 minutes)
干预措施: 5% albumin Infusion (Drug)
0.9% sodium chloride solution
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute)
干预措施: 0.9% sodium chloride solution (Drug)
结局指标
主要结局
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
时间窗: 3 hours
次要结局
- Change in lactate dynamics(3 hours)
- Total number of patients with Urine output >/= 0.5mL/kg/hr.(3 hours)
- Mortality(7 days)