A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of oral food intolerance
研究概览
简要总结
Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 AP
- •Age 18 years or older
- •Written informed consent
- •Ongoing need for opiates
排除标准
- •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
Nasogastric Tube Feeding
Patients who are to have NTF will receive enteral nutrition within 6 hours after randomisation via a nasogastric tube placed into the stomach. A commercially available low fat semi-elemental feed (Peptisorb®, Nutricia Clinical NZ) will be used. The caloric target will be 2000 kcal per day. Enteral tube feeding will be commenced at a rate of 30 mL/h and increased gradually until 100 mL/h over 24-48 h.
干预措施: Nasogastric Tube Feeding (Procedure)
Conventional Nutritional Management
Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case enteral tube feeding will be introduced) or the signs of AP mitigate,in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced.
干预措施: Conventional Nutritonal Management (Other)
结局指标
主要结局
Incidence of oral food intolerance
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
次要结局
- Progression of severity(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Pain relapse(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Use of opioids(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Duration of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
研究者
Max Petrov
Principal Investigator Dr. Max Petrov
University of Auckland, New Zealand