A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Transplant free survival in both groups
研究概览
简要总结
The AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.
All ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years to 65 years
- •ACLF patients
排除标准
- •Patients who have already received albumin in last 1 week
- •Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
- •,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
- •Not given consent
- •Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
- •Pregnant/ HIV / HCC >2cm size
- •Alcoholic hepatitis eligible for steroids
- •Previous known allergic/adverse reaction to albumin
- •Any clinical condition which the investigator considers would make the patient unsuitable for the trial
- •Patients who will receive palliative treatment only during their hospital admission
结局指标
主要结局
Transplant free survival in both groups
时间窗: 28 days
次要结局
- Transplant free survival in both groups.(7 days)
- Incidence or resolution of infection in both groups(28 day)
- Number of participant with development of new organ failure in both groups.(28 day)
- Adverse events in both groups.(28 day)