Low-Dose Albumin Infusion for the Prevention of Paracentesis Induced Circulatory Dysfunction (PICD), After Large Volume Paracentesis in Decompensated Cirrhosis of Liver.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The primary outcome
研究概览
简要总结
Abstract for thesis protocol. Background: Paracentesis induced circulatory dysfunction (PICD) is a common complication of large volume paracentesis in cirrhotic patients, which can lead to renal impairment, hyponatremia, and increased mortality. Albumin infusion is recommended to prevent PICD, but the optimal dose is unclear. We aim to compare the efficacy of low dose albumin infusion versus standard dose of albumin in preventing PICD in cirrhotic patients.
Material and methods: We will conduct a randomized controlled trial with two arms: low dose albumin infusion (2g per liter of ascitic fluid removed) versus standard dose albumin infusion (6g per liter of ascitic fluid removed). Patients with liver cirrhosis undergoing large volume paracentesis (>5 L) with serum creatinine <1.5 mg/dL and no signs of infection will be included in the study.
Sample size calculation: Based on previous studies, group sample size will be 26 and will achieve 80.749% power to reject null hypothesis. As per availability, 30 participants will be included in each group, with a total number of 60 for this trial.
Outcome of the study:
The primary outcome is the incidence of paracentesis induced circulatory dysfunction (PICD) in both groups, (Low dose albumin and standard dose of albumin), 7 days after paracentesis.
The secondary outcomes are renal failure, hyponatremia, hepatic encephalopathy, hepatorenal syndrome, and length of hospital stay.
Conclusion: This trial will provide evidence on whether low dose albumin infusion is as effective as standard dose albumin infusion in preventing PICD in cirrhotic patients. This could have implications for reducing the cost and optimal effective dose of albumin therapy, as well as improving the outcomes of patients with ascites.
详细描述
Introduction. Cirrhosis of liver is the almost final pathway of chronic liver disease, leading to hepatocellular carcinoma that become critical when it progress to decompensation, denotes 13th most common cause of death worldwide (Bai et al., 2022; Carvalho & Machado, 2018).
Ascites is the most common sign of decompensation, that markedly increase mortality in 5 years (Carvalho & Machado, 2018). Approximately 20% of patients become diuretic resistant, who were diuretic responders; and among them 10% become refractory, either due to resistance to diuretics or diuretic-intractable, because of contraindication (Alsebaey, A. et al., 2020).
Till now, apart from liver transplantation (LT), trans jugular intrahepatic portosystemic shunt (TIPS) and large volume paracentesis (LVP) are the available option for the treatment of refractory ascites, but due to chances of recurrence and hepatic encephalopathy, as well as unavailability of TIPS in some places, LVP becomes the only preferred option (Alsebaey, A. et al., 2020; Kulkarni et al., 2020; Singh et al., 2023).
Paracentesis induced circulatory dysfunction (PICD), develops invariably after LVP (Alsebaey, A. et al., 2020), leading fall of intra-abdominal pressure, that initiates increased venous return, increased CO, and decreased renin-angiotensin-sympathetic system, if plasma expander is not used (Kulkarni et al., 2020).
If volume expander not infused within 12 hours, renin-angiotensin-sympathetic system markedly activated with reduced CO, resulting in circulatory imbalance, and PICD developed (Sola-Vera et al., 2003).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Albumin infusion, 6gm/L of ascitic fluid aspiration.
干预措施: Albumin infusion, 2g/L of ascitic fluid aspiration. (Drug)
结局指标
主要结局
The primary outcome
时间窗: 6th day
The primary outcome is the incidence of PICD in both groups (low dose albumin and standard dose albumin), 7 days after paracentesis.
次要结局
- The secondary outcomes(6th day)
研究者
Abu Md Asaduzzaman
Thesis student of Doctor of Medicine (MD)
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh