Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis- A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Overall mortality.
研究概览
简要总结
Research Objectives- We hypothesized high-dose 25% albumin would be superior to standard medical treatment in improving 3-month mortality in patients with acute decompensation of cirrhosis by improving the systemic hemodynamics and amelioration of systemic inflammation, endothelial function and coagulation.
Aim: To study the efficacy of 25% albumin in reducing 3-month mortality in acute decompensation in cirrhosis.
Primary Objective
• To study the efficacy of 25% albumin in reducing the 3-month mortality.
Secondary Objectives
- To study the cumulative incidence of liver related complications (paracentesis induced circulatory dysfunction (PICD), AKI, hyponatremia, hepatic encephalopathy and variceal bleed)
- Improvement in MELD, CTP, SOFA and AARC scores
- Impact on cardiac function and systemic hemodynamics
- Impact of albumin on development of SBP and non-SBP infections
- Survival free of liver transplant and TIPS at 3 months
- Effect of albumin therapy on immunomodulation, dysfunctional albumin, endothelial function and coagulation at 3 months
- Proportion of patients achieving recompensation at 3 months
- Time to achieve serum albumin >4 g/dL and its correlation with clinical outcomes.
详细描述
Methodology
DOSING REGIMEN In this prospective cohort study, consecutive cirrhotic patients, fulfilling the inclusion criteria and exclusion criteria will be enrolled. Details of sample size calculation are given under section of statistical methods. Severity of liver disease will be assessed according to severity scores- CTP and MELD score.
The patients will be enrolled and administered high dose 25% albumin at 1.5 gm/kg/week for 12 weeks and subsequently followed for development of liver related complications, need of hospitalizations and paracentesis. The impact of albumin therapy on systemic hemodynamics, cardiac function, systemic inflammation, bacterial infections and endothelial function and coagulation will be studied. Patients would be given standard medical treatment as per the institutional protocol.
Important definitions:
Acute decompensation of cirrhosis will be defined according to the APASL criteria. This occurs in a cirrhotic with or without prior decompensation and is often associated with a precipitant. The presentation of AD is either hepatic (jaundice, ascites, HE) or extrahepatic (variceal bleed, acute kidney injury or sepsis), and time period is up to 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with acute decompensation of cirrhosis
- •Patients with age from 18-65 years
排除标准
- •Recent Gastrointestinal bleeding within 7 days
- •Patients with organic nephropathy (as defined by IAC)
- •Patients with Cardiovascular disease or chronic obstructive pulmonary disease
- •Systemic arterial hypertension (>160/90mmhg)
- •Presence of hepatocellular carcinoma (outside Milan criteria) ( or portal vein thrombosis
- •Budd-Chiari Syndrome
- •Pregnancy
- •Patients with serum albumin >3 gm
- •Refusal to participate
- •Known or suspected hypersensitivity to albumin
- •Prior TIPS
- •Post liver or kidney transplantation
- •Patients enrolled in other clinical trials
- •Extrahepatic malignancy
结局指标
主要结局
Overall mortality.
时间窗: 3 months
次要结局
- Delta change coagulation indices measured by the rotational thromboelastometry before and after albumin at 1-month.(1 month)
- Delta change in CRP.(3 months)
- Incidence of liver-related complications.(3 months)
- Delta change coagulation indices measured by the rotational thromboelastometry before and after albumin at 3 months.(3 months)
- Proportion of patients with reduction in the MELD score by at least 5 points at 3 months.(3 months)
- Proportion of patients with reduction in SOFA score by 2 points at 3 months.(3 months)
- The cumulative incidence of infections at 1 month.(1 months)
- Survival free of liver transplant and TIPS in both groups.(3 months)
- Delta change in the mean arterial pressure in mm of Hg before and after albumin.(3 months)
- Delta change in IL-6.(3 months)
- Proportion of patients with reduction in the MELD score by at least 5 points at 1 month.(1 month)
- Proportion of patients with reduction in the SOFA score by 2 points at 1 month.(1 month)
- The cumulative incidence of infections at 3 month.(3 months)
- Proportion of patients achieving recompensation.(3 months)
- Proportion of patients with reduction in the AARC grade by 1 at 1 month.(1 month)
- Proportion of patients with reduction in AARC grade by 1 at 3 months.(3 months)