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临床试验/NCT01998334
NCT01998334Unknown不适用

Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The Efficiency of CBP with Inflammatory Response

研究概览

简要总结

Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to control SIRS. But the detail treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three kinds of treatment protocols which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three groups. This study will try to find a better way for CBP in patients with SAP

详细描述

Condition Severe Acute Pancreatitis

Intervention CVVH 6 hours for first three days CVVH 10 hours for first three days CVVHDF 6 hours for first three days

All therapeutic volume is 45ml/kg.h, Device: Braxter HF 1200

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

入选标准

  • Inclusion Criteria:
  • Diagnosis of pancreatitis:
  • Typical pain
  • Increase in serum lipase or amylase
  • Onset of abdominal pain within <=72h before admission
  • The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
  • no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on
  • Age from 18 to 65 years old
  • Besides criteria above, the patient should also satisfied one of these CBP criteria:
  • Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine > 1.5 times baseline,26.5umol/L increase, or urine output < 0.5ml/kg.h for 6 hours
  • Systemic Inflammatory Response Syndrome: temperature >38℃ or<36℃;heart rate respiratory rate White blood cell count >12*10^9/L,or< 4*10^9/L
  • Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.

排除标准

  • Chronic pancreatitis
  • Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell < 0.5*10^9/L for 10 days

结局指标

主要结局

The Efficiency of CBP with Inflammatory Response

时间窗: 3 days

Efficiency of CBP with inflammatory response was assessed by the following measurements: 1. Inflammatory mediators removal:tumor necrosis factor-α, interleukin(IL-1, IL-2, IL-6, and IL-8, IL-10, sIL-2R)before and after CBP in first three days 2. SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days

次要结局

  • operation time(28 days)
  • mortality(28 days)
  • local complication of severe acute pancreatitis(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erzhen Chen

Professor

Ruijin Hospital

研究点 (1)

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