Effect of Pancreatic Enzyme Supplementation on 90-days hospital free alive days in patients with Acute Necrotizing Pancreatitis (ANP): A multicenter double blinded placebo-controlled randomizedTrial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 248
- 试验地点
- 3
- 主要终点
- Days alive and out of hospital at 90 days. It will be counted as number of days the patient is not in hospital and alive. This parameter will take into account total duration of readmissions and mortality.
研究概览
简要总结
The PEAP trial is a study to assess the usefulness of PERT (pancreatic enzyme replacement therapy) in acute necrotizing pancreatitis. It is designed as a double blind placebo controlled randomized trial to assess the 90 day alive and hospital free days in patients with ANP. The days alive and out of hospital at 90 days (DAOH-90) is novel metric to assess outcome in critical illness as it measures survival and length of hospital stay. Increase in DAOH 90 represents an important clinically relevant outcome. A total of 248 patients with acute necrotizing pancreatitis will be recruited from three study sited in India. All patients will be treated as per standard of care. At the time of discharge patients will requested for consent to participate in the trial. After obtaining informed consent, enrolled patients will be randomized to receive either PERT at 25000 IU with every meal or an identical placebo at discharge. They will be followed up 2 weekly over telephone till ninety days of recruitment. The outcome will be assessed at 90 days for – Days Alive and out of hospital at 90 days (DAOH 90 ). DAOH 90 will be calculate as below: DAOH 90 = Number of days alive (within 90days of follow up) – (Total hospitalization days at readmission). In addition to the DAOH 90 we will also measure the readmission rates, nutritional status, and quality of life.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Acute pancreatitis with pancreatic necrosis within 14 days of pain, Able to take oral or enteral feed, pancreatic necrosis more than 30%.
排除标准
- •Patients with Chronic Pancreatitis, Patients with more multi-organ failure at time of screening, Patient on ventilatory support, Pregnancy, Contraindication to enteral feeding or not tolerating enteral feed, Age lesser than 18 years or more than 75 years, Major comorbidity such as decompensated cirrhosis heart failure significant lung parenchymal or airway disease advanced chronic kidney disease, Previous pancreatic surgery, Known allergy to pancreatic enzyme supplementation components.
结局指标
主要结局
Days alive and out of hospital at 90 days. It will be counted as number of days the patient is not in hospital and alive. This parameter will take into account total duration of readmissions and mortality.
时间窗: 90 days
DAOH90= Number of days alive (within 90 days of follow up) – (Total hospitalization days at readmission).
时间窗: 90 days
次要结局
- a. All cause mortality(b. Mean change in body weight from baseline in both groups)
研究者
Sudipta Dhar Chowdhury
Christian Medical College, Vellore