acute pancreatitis
Conditions
Interventions
Test Group:High-Dose Ulinastatin
Control group:low dose Ulinastatin
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 ~ 70, no gender limit; 2. Meets the AP diagnostic criteria, defined by two of the following: Abdominal pain with AP characteristics (acute, persistent upper abdominal or generalized pain, with or without radiating pain); Serum amylase or lipase levels exceeding three times the upper limit of normal; Imaging findings (abdominal ultrasound, CT, or MRI) showing characteristic AP changes such as pancreatic enlargement, exudation, or necrosis. 3. Triglycerides >=11.30 mmol/L; 4. 48h disease course; 5. Willing to comply with the study protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Simultaneous biliary tract pathologies, such as choledochal stones, or the following three laboratory abnormalities: (1) serum bilirubin concentration>1.9 mg/dL(33.4umol/L; (2) alanine aminotransferase (ALT) activity>100µ/L with ALT>AST; (3) alkaline phosphatase (AKP) activity>195 U/L and ?-glutamyl transferase (GGT) activity>30 U/L. 2. The combined alcohol-related causes include: consuming >=50 g of alcohol per day for over 5 years. 3. Pregnant or lactating women; 4. Previous history of Ulinastatin allergy; 5. History of chronic pancreatitis or pancreatic tumor; 6. Patients with acute respiratory failure, acute renal failure, and circulatory failure (shock). 7. Pre-existing serious underlying diseases (including chronic obstructive pulmonary disease, chronic heart failure, chronic renal failure, malignant tumor, immunodeficiency disease, etc.). 8. The ability to think and act is partially or completely limited, and the person has no autonomous decision-making ability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new-onset organ failure;Incidence of Pancreatic Necrosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;Metabolic and biochemical indicators;Hospitalized mortality rate;Number of days without organ failure in 14 days;Prevalence of multiple organ dysfunction syndrome (MODS);28-day mortality rate;Inflammatory markers;ICU case fatality rate;Hospitalization time and intensive care time;Sequential Organ Failure Assessment (SOFA) score; | — |
Countries
China
Contacts
Public ContactWenhua He
The First Affiliated Hospital of Nanchang University
Outcome results
None listed