Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mortality in both groups
研究概览
简要总结
Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.
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
- •Cirrhosis with septic shock.
- •Age >18 years
排除标准
- •Previous severe adverse reaction with blood products,
- •Disseminated intravascular coagulopathy
- •Active gastrointestinal bleeding
- •Intracranial bleeding
- •Chronic Kidney disease with Maintenance Hemodialysis
- •Pulmonary Edema
- •Congestive Heart Failure
- •Lack of informed consent
研究组 & 干预措施
Liberal
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
干预措施: Liberal (Biological)
Restrictive
To maintain the target Hemoglobin of 7 to 8 gm/dL.
干预措施: Restrictive (Other)
结局指标
主要结局
Mortality in both groups
时间窗: 28 dyas
次要结局
- Length of ICU (Intensive Care Unit) stay(28 days)
- Requirement of mechanical ventilation in both groups(28 days)
- Improvement in vasopressors in both groups(28 days)
- Incidence of complications in both groups(28 days)