Assessment of Cytokine Profile in an Open Labeled Randomized Controlled Trial of Standard Dose vs. Once a Day Intravenous Albumin in Patients With Spontaneous Bacterial Peritonitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Change in neutrophils/mm in ascitic fluid
研究概览
简要总结
The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Diagnosis of SBP
- •Age > 18 years
- •Consent to participate in the trial
排除标准
- •Secondary peritonitis
- •Malignancies including HCC
研究组 & 干预措施
STANDARD DOSE
Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3
干预措施: ALBUMIN (Drug)
LOW DOSE
Albumin 20g/d for 5 days
干预措施: ALBUMIN (Drug)
结局指标
主要结局
Change in neutrophils/mm in ascitic fluid
时间窗: 3 days
Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups
时间窗: 5 days
次要结局
- Survival in days at the end of therapy(5 days)
- Differences in frequency of sepsis, renal failure and other organ failures between the two groups(5 days)
研究者
Subrat Kumar Acharya
Professor and Head, Department of Gastroenterology
All India Institute of Medical Sciences, New Delhi