NCT03433508撤回不适用
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Restrictive Versus Liberal Red Cell Transfusion Strategy in Orthopedic-Oncology Patients Undergoing Surgery - a Randomized Controlled StudyRed Blood Cells Transfusion.NCT01491308Tel-Aviv Sourasky Medical Center10
终止
不适用
Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip ArthroplastyArthroplasty, HipNCT01452581Rigshospitalet, Denmark5
已完成
不适用
Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill PatientsEffect of RBC Transfusions on Cerebral Oxygen SaturationNCT02232412Johann Wolfgang Goethe University Hospital25
已完成
2 期
Adverse Effects of RBC Transfusions: A Unifying HypothesisHealthy VolunteersNCT00838331Emory University24
已完成
不适用
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University HospitalPRBC TransfusionCABGsNCT02585310Mahidol University300
