Acute Pancreatitis
Conditions
Keywords
severe acute pancreatitis, organ failure, multiple organ dysfunction syndrome, systemic complications, continuous veno-venous hemofiltration, blood purification, continuous renal replacement therapy
Brief summary
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
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.
Interventions
DEVICEAN69 hemofilter
An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.
OTHERconventional treatments
Patients receive conventional treatments recommended by guidelines only.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| persistent organ failure or death | 1 months | persistent organ failure: organ failure ≥ 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| persistent organ failure | 1 months | — |
| infectious complications | 1 months | infected necrosis,bacteraemia and pneumonia respectively |
| input fluid volume within first 3 days after admission | 3 days | crystalloid fluids and colloid fluids respectively |
| Physiological Parameters 1 day, 2 days, and 3 days after randomization | 3 days | Physiological Parameters: APACHE-II score,SOFA score,Body temperature,PaO2/FiO2,BE,PLT,Cr,serum Ca,WBC and Urine volume |
| 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 | 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 |
| total number of surgical interventions | 2 months | for any purpose |
| death | 1 months | — |
| total costs in hospital | 3 months | — |
| output fluid volume in the first, second, third day after admission | 3 days | output: urine volume,ultrafiltration liquids,gastric drainage and defecation |
| persistent multiple organ dysfunction syndrome | 1 months | multiple organ dysfunction syndrome (two or more organs or occurrence of two or more systemic complications at the same time) ≥ 48 hours |
| new-onset organ failure | 1 months | not present at any time in the 24 hours before randomization |
| new-onset multiple organ dysfunction syndrome | 1 months | — |
| ICU stay | 2 months | — |
Countries
China
Contacts
Primary ContactZhao Qingchuan, PhD & MD
Backup ContactZhang Xujie, MD
Outcome results
None listed