NCT01247961撤回2 期
Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Systemic Inflammation (measured by c-reactive protein level)
研究概览
简要总结
This pilot trial will evaluate the following in patients with acute pancreatitis:
- Safety profile of early treatment with intravenous dexamethasone
- Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
- Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18 years
- •Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
- •Typical epigastric abdominal pain
- •Elevation amylase/lipase >3 times upper limit normal and/or
- •Confirmatory findings on cross-sectional imaging
- •Enrollment within 8 hours of presentation
排除标准
- •Class II or greater NYHA heart failure
- •Oxygen dependent COPD
- •Chronic kidney disease>stage 2
- •Cirrhosis
- •Existing necrosis on abdominal CT
- •Organ dysfunction prior to enrollment
- •Acute respiratory distress syndrome
- •Malignancy not in remission for at least 5 years
- •Active drug use
- •Known allergy to dexamethasone
- •Altered mental status
- •Insulin-requiring diabetes
- •Abdominal surgery within 60 days
研究组 & 干预措施
10 mg intravenous dexamethasone
Experimental
Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.
干预措施: Dexamethasone acetate (Drug)
Placebo
Placebo Comparator
Equal volume of normal saline administered as a single intravenous dose at enrollment.
干预措施: Placebo (Other)
结局指标
主要结局
Systemic Inflammation (measured by c-reactive protein level)
时间窗: 48 hours
C-reactive protein (CRP) is a well-established inflammatory prognostic marker in acute pancreatitis. Primary comparison will be between median CRP levels at 48 hours between treatment arms.
次要结局
- Safety parameters(72 hours post-randomization)
- Composite clinical outcome(Up to 14 days from hospital admission)
研究者
Bechien Wu, MD, MPH
Physician, Center for Pancreatic Disease
Brigham and Women's Hospital
研究点 (1)
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