NCT02897206已完成4 期
Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis
University Hospital Rijeka1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Infectious complications
研究概览
简要总结
This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria
- •first manifestation of acute pancreatitis regardless of etiology
- •APACHE II ≥ 8 calculated within the first 24 hours of admission
- •onset of symptoms < 72 hours before admission
排除标准
- •age < 18 years
- •pregnant and breastfeeding women
- •active and documented infection at admission
- •concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment
- •acute pancreatitis diagnosed at surgery
- •active malignancy
- •known immune deficiency
- •patients with chronic pancreatitis
- •patients unwilling to participate in the trial
研究组 & 干预措施
Imipenem group
Experimental
Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days)
干预措施: Imipenem (Drug)
Placebo group
Placebo Comparator
Identical placebo administered in identical dosage, timing and duration.
干预措施: Placebo (Drug)
结局指标
主要结局
Infectious complications
时间窗: 30 days
次要结局
- Mortality(30 days)
- Number of patients with Systemic Inflammatory Response Syndrome (SIRS)(30 days)
- Local complications(30 days)
- Systemic complications(30 days)
- Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal)(30 days)
- Surgical interventions(30 days)
- Serious adverse events(30 days)
研究者
Goran Poropat
Postdoctoral Researcher
University Hospital Rijeka
研究点 (1)
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