acute pancreatitis
Conditions
Interventions
high-dose ulinastatin group:On the basic of conventional treatment. In the ulinastatin group, 400000 U of ulinastatin dissolved in 100 mL of saline will be administered intravenously, IV for 1-2 hours
Placebo control group:On the basis of conventional medicine treatment,the control group will be given 100ml 0.9% sodium chloride injection as placebo treatment. IV for 1-2 hours, q8h, 15 doses requir
Sponsors
The First Affiliated Hospital of the Chinese People's Liberation Army Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old, male or female 2.Acute persistent abdominal pain with or without radiating pain; blood amylase more than 3 times the normal cut-off value; imaging such as abdominal ultrasound, enhanced CT or MRI to detect the manifestation of acute pancreatitis, 2 of the above 3 items meet, diagnosis of acute pancreatitis and the onset of the disease = 5 days 3. AP patients with SIRS 4. Consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1.With single or multiple organ failure 2. Acute biliary pancreatitis with acute cholangitis, acute biliary pancreatitis requiring emergency ERCP, pancreatitis in pregnancy 3. Combined pancreatic tumours 4, with definite infection (sepsis, peripancreatic infection, pulmonary infection, etc.) 5, combined with severe underlying disease (e.g. heart failure, chronic liver disease, chronic kidney disease, severe diabetes, etc.) 6, previous history of allergy to ulinastatin and other related drugs 7. Patients who have used ulinastatin, Gabexate or undergone blood purification therapy within the last 1 week 8. Patients who are considered by clinicians to be unsuitable for clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SIRS relief rate on day 5; | — |
Secondary
| Measure | Time frame |
|---|---|
| SIRS Duration;SIRS relief rate on day 3 and day 7;SIRS score;Mortality rate within 28 days;Number and percentage of new pancreatic infections with necrosis and organ failure during hospitalization;Days of hospitalization; | — |
Countries
China
Contacts
Public Contactyiqi du
The First Affiliated Hospital of the Chinese People's Liberation Army Naval Military Medical University
Outcome results
None listed