NCT02813876已完成2 期
Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Time to tolerance of oral refeeding
研究概览
简要总结
Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with 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
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging
排除标准
- •• Severe acute pancreatitis defined as the presence of any of the following:
- •Organ failure (oxygen saturation<90% on room air, mean arterial pressure<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine>2.0, Glasgow coma score<15)
- •Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate
- •Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization
- •Abdominal surgery within 60 days prior to hospitalization
- •History of gastrointestinal motility disorder
- •Inflammatory bowel disease
- •Chronic comorbid illness including but not limited to >New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission.
- •Documented allegy to any of the following medications: dilaudid, Tylenol
- •Patients transferred from an outside hospital for ongoing care
- •Non-English speaking patients for whom an appropriate language interpretor cannot be identified.
- •Pregnant women will be excluded from participation in this phase IIb trial given the limited projected sample size and rarity of this condition during pregnancy.
- •Minors (patients <18 years of age) will not be eligible for study inclusion. The interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. However, the safety and efficacy of these treatments in the pediatric population has not been established.
结局指标
主要结局
Time to tolerance of oral refeeding
时间窗: Up to 7 days
Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting
次要结局
- Satisfaction with inpatient hospital care(30 days post-hospitalization)
- Time to disease resolution(Up to 30 days)
研究者
Bechien U. Wu
Center for Pancreatic Care
Kaiser Permanente
研究点 (2)
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