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| ID | Type | Description | Link |
|---|---|---|---|
| 81170432 | Other Grant/Funding Number | the National Natural Science Foundation of China |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EHVCVVH group | Active Comparator | Patients receive conventional treatments recommended by guidelines with adjunctive early high-volume continuous veno-venous hemofiltration (EHVCVVH). |
|
| Control group | Active Comparator | Patients receive conventional treatments recommended by guidelines only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN69 hemofilter | Device | An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| persistent organ failure or death | persistent organ failure: organ failure ≥ 48 hours | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| death | 1 months | |
| persistent organ failure | 1 months | |
| infectious complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Qingchuan, PhD & MD | Contact | 86-29-84771503 | zhaoqc@fmmu.edu.cn | |
| Zhang Xujie, MD | Contact | 86-13991230324 | 602914766@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao Qingchuan, PhD & MD | the First Affiliated Hospital of Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012769 | Shock |
| D010335 | Pathologic Processes |
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| conventional treatments | Other | Patients receive conventional treatments recommended by guidelines only. |
|
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |