Effects of Maintaining Steady Albumin Levels by Targeted Albumin Therapy (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites and Low Serum Albumin Level- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
研究概览
简要总结
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (<2.8g/dl) with ascites.
详细描述
Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly detected cirrhotic patients aged more than 18 years
- •Cirrhosis defined by standard clinical, analytical and/or histological criteria
- •Serum albumin level < 2.8g/dl with or without ascites
- •Who would agree to give written informed consent
排除标准
- •Uncontrolled HTN (sys>150/ dis >90 mmHg) or h/o any drug therapy for HTN
- •Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- •Hepatocellular Carcinoma
- •Active alcohol abuse within 3 months
- •Patients presenting as Acute on Chronic Liver Failure
- •Extrahepatic organ failure
- •Known case of chronic heart failure or respiratory failure
- •Diagnosed Chronic Kidney Disease
- •Patients with hydrothorax
- •Prior liver transplant recipient
- •Human Immunodeficiency Virus infection
- •Use of albumin infusion in the last one month
- •CTP>12, MELD>28
- •Total Bilirubin >3 g/dl
- •Overt Hepatic Encephalopathy at Presentation
研究组 & 干预措施
Albumin
Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy
干预措施: ALB Protein, Human (Drug)
Placebo
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
时间窗: 12 months
1 year survival
次要结局
- Hepatic encephalopathy grade 3 or 4 in both groups(12 months)
- Number of new cases with gastrointestinal bleeding in both groups(12 months)
- Number of hospitalizations per subject in both groups(12 months)
- Spontaneous bacterial peritonitis [SBP] in both groups(12 months)
- Renal impairment in both groups(12 months)
- Hepatorenal Syndrome in both groups(12 months)
- Requirement of diuretics in both groups(12 months)
- New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups(within 24 hours)
- New onset refractory ascites in both the groups(12 months)
- Requirement of paracentesis in both groups(12 months)
- Quality of life by Ascite-Q questionnaire in both groups(12 months)
研究者
Shasthry SM
Associate Professor
Institute of Liver and Biliary Sciences, India