Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reversal of hypotension in both groups
研究概览
简要总结
Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of cirrhosis with suspected or documented sepsis with MAP < 65 mm Hg
排除标准
- •Age <18 years or > 75 yrs
- •Already received colloid or 2 litres of fluid within the first 12 hours of presentation
- •Already on vasopressors and/or inotropes
- •Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl
- •Patient with structural heart disease
- •On maintenance hemodialysis
- •Other causes of hypotension
- •Pregnant or lactating women
- •Patients in need for emergent surgical interventions
- •Known chronic obstructive lung disease and congestive heart failure
- •A previous adverse reaction to human albumin solution
结局指标
主要结局
Reversal of hypotension in both groups
时间窗: 3 hours
Reversal is defined as Mean Arterial Pressure (MAP) \> 65 mmHg after 3 hours of resuscitation
次要结局
- Mortality in both groups(7 days)
- Survival time during the first 28 days(28 days)
- Proportion of patients with new organ failures.(28 days)
- Duration of mechanical ventilation.(28 days)
- Requirement of renal-replacement therapy.(28 days)
- The duration of the Intensive Care Unit stay.(28 days)