Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early High-volume Continuous Veno-venous Hemofiltration for Patients With Severe Acute Pancreatitis: Single-center, Randomized, Controlled Trial

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Device: AN69 hemofilter
* Other: conventional treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of severe acute pancreatitis written informed consent Time from onset of abdominal pain to admission ≤ 72 hours SIRS score ≥ 2 Exclusion Criteria: 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

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 |
| --- | --- |
| Active Comparator: EHVCVVH group<br>Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH). | Device: AN69 hemofilter<br>* An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.<br>* Other names: high-volume hemofiltration;|
| Active Comparator: Control group<br>Patients receive conventional treatments recommended by guidelines only. | Other: conventional treatments<br>* Patients receive conventional treatments recommended by guidelines only.<br>* Other names: standard treatments;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| persistent organ failure or death | persistent organ failure: organ failure ≥ 48 hours | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 1 months | 
| persistent organ failure |  | 1 months | 
| infectious complications | infected necrosis,bacteraemia and pneumonia respectively | 1 months | 
| input fluid volume within first 3 days after admission | crystalloid fluids and colloid fluids respectively | 3 days | 
| Physiological Parameters 1 day, 2 days, and 3 days after randomization | Physiological Parameters: APACHE-II score,SOFA score,Body temperature,PaO2/FiO2,BE,PLT,Cr,serum Ca,WBC and Urine volume | 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 | inflammatory mediators: tumor necrosis factor-α, IL-1, IL-2, IL-4, IL-6, and IL-8, IL-10, IL-13, IL-15, Angiopoietin-2, trypsin, resistin and visfatin | 12 hours | 
| total number of surgical interventions | for any purpose | 2 months | 
| ICU stay |  | 2 months | 
| total costs in hospital |  | 3 months | 
| output fluid volume in the first, second, third day after admission | output: urine volume,ultrafiltration liquids,gastric drainage and defecation | 3 days | 
| persistent multiple organ dysfunction syndrome | multiple organ dysfunction syndrome (two or more organs or occurrence of two or more systemic complications at the same time) ≥ 48 hours | 1 months | 
| new-onset organ failure | not present at any time in the 24 hours before randomization | 1 months | 
| new-onset multiple organ dysfunction syndrome |  | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy