NCT01595672Unknown不适用
Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- persistent organ failure or death
研究概览
简要总结
The purpose of this study is to determine the effect and safety of early high-volume continuous veno-venous hemofiltration for patients with severe acute pancreatitis.
详细描述
The investigators anticipated that early high-volume continuous veno-venous hemofiltration (EHVCVVH) would result in a decrease of the composite of persistent organ failure or death by eliminating inflammatory mediators in blood. This study is designed to evaluate the impact of EHVCVVH on patients with severe 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of severe acute pancreatitis
- •written informed consent
- •Time from onset of abdominal pain to admission ≤ 72 hours
- •SIRS score ≥ 2
排除标准
- •confirmed infection
- •pregnancy
- •patients needing emergency operation for abdominal compartment syndrome
- •chronic renal diseases needing blood purification
- •previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
- •acute flare-up of chronic pancreatitis
- •malignancy
结局指标
主要结局
persistent organ failure or death
时间窗: 1 months
persistent organ failure: organ failure ≥ 48 hours
次要结局
- death(1 months)
- persistent organ failure(1 months)
- infectious complications(1 months)
- input fluid volume within first 3 days after admission(3 days)
- Physiological Parameters 1 day, 2 days, and 3 days after randomization(3 days)
- The concentration of inflammatory mediators in serum 0 hour,2 hours,6 hours and 12 hours after early high-volume continuous veno-venous hemofiltration(12 hours)
- total number of surgical interventions(2 months)
- ICU stay(2 months)
- total costs in hospital(3 months)
- output fluid volume in the first, second, third day after admission(3 days)
- persistent multiple organ dysfunction syndrome(1 months)
- new-onset organ failure(1 months)
- new-onset multiple organ dysfunction syndrome(1 months)
研究者
Qingchuan Zhao
Clinical Professor
Air Force Military Medical University, China
研究点 (1)
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