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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Other: CVVH 6h
* Other: CVVH 10h
* Other: CVVHDF 6h


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVVH 6h<br>CVVH 6h for first three days | Other: CVVH 6h<br>* CVVH 6h for first three days<br>|
| Experimental: CVVH 10h<br>CVVH 10h for first three days | Other: CVVH 10h<br>* CVVH 10h for first three days<br>|
| Experimental: CVVHDF<br>CVVHDF 6h for first three days | Other: CVVHDF 6h<br>* CVVHDF 6h for first three days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficiency of CBP with Inflammatory Response | Efficiency of CBP with inflammatory response was assessed by the following measurements: 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 SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Mortality of 28 days | 28 days | 
| operation time | operation time of 28 days | 28 days | 
| local complication of severe acute pancreatitis | local complication of SAP in 28 days | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Inflammatory Response Syndrome, Continuous Blood Purification