Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Serum albumin level
研究概览
简要总结
The rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. Serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. However, the role of albumin infusion in patients with hepatocellular carcinoma (HCC) after resection is unknown. The present study aimed to investigate the safety and clinical necessity of albumin infusion for HCC patients after hepatic resection.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index >18.5;
- •Patients with primary hepatocellular carcinoma without any treatments for tumors before resection;
- •Hepatocellular carcinoma should be confirmed by histopathology;
- •With preserved liver function (Child-Pugh score ≤7) before resection
- •ECOG performance score 0 or 1;
- •Preoperative serum albumin >35g/L;
- •The level of postoperative serum albumin is between 25-30g/L in the first day after resection.
排除标准
- •Patients used albumin before liver resection (<1 months);
- •Plasma was used during or after liver resection;
- •Surgery involving the extrahepatic bile duct or gastrointestinal tract.
研究组 & 干预措施
Albumin infusion group
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after hepatic resection in 24 h for three days. All patients wil receive furosemide (10 mg, iv) after albumin transfusion. In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula).
干预措施: Albumin infusion (Drug)
结局指标
主要结局
Serum albumin level
时间窗: Change from Baseline serum albumin at the fifth and seventh days after resection
Recovery of liver function between the two groups
Serum total bilirubin level
时间窗: Change from Baseline total bilirubin at the fifth and seventh days after resection
Recovery of liver function between the two groups
次要结局
- Rate of postoperative complications(The first months after resection)
- Abdominal girth(Change from Baseline abdominal girth at the fifth and seventh days after resection)
研究者
Jian-Hong Zhong
Principal Investigator
Guangxi Medical University