To Assess the Comparative Efficacy of Full Calorie Regular Diet (RD) Versus Clear Liquid Diet (CLD) on Length of Hospital Stay (LOHS) for Mild to Moderate Acute Pancreatitis (AP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Length of Hospitalization Stay
研究概览
简要总结
Acute pancreatitis is among the most common gastroenterology diagnosis in the United States, and represents a large economic burden to the United States health system. While recent guidelines agree early feeding shortens length of stay, these guidelines fail to provide recommendations on optimal diet to start leaving diet type to clinician discretion. Therefore, the aim is to assess the comparative efficacy of full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP). The study population will target mild to moderate acute pancreatitis patients who can tolerate eating in a single institution. The primary end point will focus on LOHS, and secondary end points will include Pancreatic Activity Scoring System, side effects and readmission.
详细描述
Purpose: To assess the comparative efficacy of initial full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP).
Study Design:
Patients presenting to the Los Angeles County Hospital with mild to moderate acute pancreatitis are eligible and are the focus population of this study. Diagnosis and severity classification will be according to the Revised Atlanta classification and Modified Marshal Score. Patients will require fulfillment of 2 of 3 criteria: amylase or lipase greater than 3 times the upper limit of normal, classic epigastric abdominal pain, or unequivocal imaging consistent with acute pancreatitis.
Patients within the inclusion and exclusion parameters will be randomized to RD vs. CLD within 16 hours of diagnosis of pancreatitis. Randomization will be performed using a random sequence algorithm with concealed allocation. The provision of diet in the emergency department prior to randomization will be recorded but not impact randomization strategy.
Following randomization, the diet of RD vs. CLD will begin as soon as patient expresses an appetite and willingness to eat. The patients will be assessed within 24 hours for hunger and interest in initiating oral feeding which accords with the 2018 recommendations of the American Gastroenterology Association for the management of acute pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •>18 years of age
- •Presentation with acute pancreatitis as defined by two of three criterion per the Revised Atlanta Criteria guidelines: (a) Amylase or lipase > 3x the upper limit of normal, b) Classical abdominal pain, c) Ultrasound or computed tomography of unequivocal pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding
排除标准
- •Pregnant or breastfeeding women
- •Incarcerated patients
- •Patients < 18 years of age
- •Patient unable or unwilling to give informed consent
- •Patients transferred from another hospital
- •The possibility of poor oral intake for reasons other than acute pancreatitis (e.g. intubation, failure to pass an indicated swallow study for aspiration risk, anorexia secondary to active malignancy, etc)
- •Surgical intervention for infected pancreatic necrosis or pancreatic hemorrhage
- •Chronic pancreatitis based on radiographic evidence
- •Severe pancreatitis based on Revised Atlanta Criteria. Under Revised Atlanta Criteria, patients will be excluded if they have a composite Modified Marshall >2
- •Etiologies of hypertriglyceridemia, trauma and autoimmune pancreatitis will be excluded
结局指标
主要结局
Length of Hospitalization Stay
时间窗: From date of randomization until the date of discharge, assessed up to 24 months
Length of Hospitalization Stay will be measured as defined as from time of admission to time of discharge for regular diet vs. clear liquid diet
次要结局
- Oral Intolerance(From date of randomization until the date of discharge, assessed up to 24 months)
- Local complications(From date of randomization until the date of discharge, assessed up to 24 months)
- Change in Pancreatic Activity Scoring System Score(From date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months)
- 30 day hospital readmission(From date of discharge to 30 days after discharge)
- Intensive Care Unit admission and interventions(From date of randomization until the date of discharge, assessed up to 24 months)
- Calorie and fat intake(From date of randomization until the date of discharge, assessed up to 24 months)
- Development of severe pancreatitis(From date of randomization until the date of discharge, assessed up to 24 months)
研究者
James Buxbaum
Chief of Gastroenterology Los Angeles County + University of Southern California
University of Southern California