A randomized double-blind placebo-controlled trial to evaluate the effect of Rifaximin to reduce the incidence of infected pancreatic Necrosis in patients with Acute necrotizing pancreatitis without persistent organ failure.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Infected (peri) pancreatic fluid collections.
研究概览
简要总结
Acute pancreatitis is a common inflammatory disease of the pancreas with a significant healthcare burden. While most cases are mild and self-limiting, approximately 10-20% of patients progress to moderately severe or severe AP, which carries a high risk of complications. Overall mortality of AP patients is approximately 5% and can reach up to 20-30% in patients with severe acute pancreatitis and infected necrosis. One of the most concerning complications is infectious complications, occurring in up to 40-70% of patients with acute necrotizing pancreatitis. Rifaximin offers a targeted approach with a favourable safety profile. Rifaximin has emerged as a potential therapeutic option for gut decontamination in various GI disorders. Previous research on rifaximin in acute pancreatitis has been limited. Administration of rifaximin reduces infectious complications and hospital readmission rates in patients with moderately severe and severe acute pancreatitis with peripancreatic collections compared to placebo. This randomized controlled trial is needed to definitively assess efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults (age 12-75 years) diagnosed with acute necrotizing pancreatitis without any persistent organ failure presenting beyond first week till 6 week of onset of illness.
排除标准
- •Persistent organ failure
- •evidence of infected pancreatic necrosis at time of screening
- •prior drainage and/or necrosectomy
- •contraindication to enteral feeding or not tolerating enteral feed
- •Major comorbidity such as decompensated cirrhosis, heart failure, significant lung parenchymal or airway disease, advanced chronic kidney disease
- •pregnancy
- •patients with chronic pancreatitis
- •refusal to give consent.
结局指标
主要结局
Incidence of Infected (peri) pancreatic fluid collections.
时间窗: From randomization to 90 days.
次要结局
- Need for drainage of collection (endoscopic, percutaneous or surgical)(Need for necrosectomy)
研究者
Dr Pramod Garg
All India Institute of Medical Sciences
