A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Oral food intolerance
研究概览
简要总结
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.
In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of acute pancreatitis
- •age > 18 years
- •written informed consent
排除标准
- •ongoing need for opiates
- •>96 hours after onset of symptoms
- •chronic pancreatitis
- •post-ERCP pancreatitis
- •intraoperative diagnosis
- •pregnancy
- •malignancy
- •received nutrition before randomisation
研究组 & 干预措施
Patient-controlled oral refeeding
Patients will be allowed to drink and eat hospital food freely as tolerated.
干预措施: Patient-controlled oral refeeding (Other)
Conventional management
结局指标
主要结局
Oral food intolerance
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 7 days
次要结局
- Time from admission until tolerance of oral food(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in plasma C-reactive protein(Baseline and 24, 48, 72h after randomisation)
- Need for opiates(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Hospital readmission(2 weeks after hospital discharge)
- Total length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in pain intensity(Baseline and 24, 48, 72h after randomisation)
- Progression of acute pancreatitis severity(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Local and systemic complications(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Time from admission until first flatus(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in blood glucose(Baseline and 24, 48, 72h after randomisation)
- Number and type of interventions during hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
研究者
Max Petrov
Prinicpal Investigator Dr. Max Petrov
University of Auckland, New Zealand