Impact of Early Nutrition Support on Clinical and Metabolic outcomes in Subjects with Pancreatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- improvement in Antioxidant levels of patients in case group, improvement in clinical and metabolic outcomes evidenced by biochemical parameters
研究概览
简要总结
This study is randomized , case control study where a disease specific formulation with immuno nutrition will be given orally or enterally to patients with Pancreatitis who are admitted to hospital. Clinical and Metabolic outcomes of patients will be analysed for improvement and decreased length of hospital stay. The formula will be fortified with micronutrients and immuno nutrients in the safe limit. Intervention will be started within the 48 hours after admission and will be continued until discharge. Recruitment of subjects will be conducted in various hospitals in Mysore district. The primary outcome and secondary outcome will be measured using biochemical parameters and and clinical signs and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •subjects diagnosed with Pancreatitis and who have accessable Gastrointestinal tract for feeding either rally or enterally.
- •both acute and chronic subects will be included.
排除标准
- •Subjects who are haemodynamically unstable and whose gastrointestinal tract cannot be accessed for oral or enteral feeds.
- •Pregnant females with pancreatitis and patients with renal and or cardiac complications are excluded.
结局指标
主要结局
improvement in Antioxidant levels of patients in case group, improvement in clinical and metabolic outcomes evidenced by biochemical parameters
时间窗: day 1,3,7 and during time of discharge
次要结局
- Decrease in length of hospital stay as compared to control group(time of discharge)