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The application of Ulinastatin in patients with moderate and severe acute pancreatitis: a real-world study

The application of Ulinastatin in patients with moderate and severe acute pancreatitis: a real-world study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102668
Enrollment
Unknown
Registered
2025-05-19
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis (AP)

Interventions

Ulinastatin Group:NA

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with "acute pancreatitis" are defined as follows: (1) Patients diagnosed with "acute pancreatitis" between January 1, 2018, and December 31, 2023, with the primary diagnosis of "acute pancreatitis" upon admission or discharge. (2) Patients diagnosed with "pancreatitis" and meeting at least two of the following criteria: - For patients meeting the criteria for "pancreatitis" but without a clear diagnosis of "acute pancreatitis," the database should be searched for patients diagnosed with "pancreatitis" between January 1, 2018, and December 31, 2023. The hospitalizations where the diagnosis was "pancreatitis" should be identified, and the clinical diagnosis of "acute pancreatitis" should be determined through text, laboratory tests, and imaging examinations. Meeting two out of the following three criteria constitutes a diagnosis of "acute pancreatitis": - Relevant descriptions in the patient's medical records such as "acute persistent abdominal pain, with or without radiation pain." - Serum amylase levels upon admission exceeding three times the upper limit of normal. - Imaging findings (e.g., abdominal ultrasound, contrast-enhanced CT, or MRI) upon admission showing features of acute pancreatitis. Furthermore: - Patients must receive inpatient treatment for acute pancreatitis. - Patients must meet the criteria for moderate to severe acute pancreatitis and experience one of the following conditions during hospitalization for "acute pancreatitis": - Local complications (acute peripancreatic fluid collection, pseudocyst, acute necrotic collection, walled-off necrosis). - Organ failure during hospitalization (renal failure, liver failure, respiratory failure, circulatory failure, multiple organ dysfunction syndrome). - Other complications (sepsis, systemic inflammation reaction syndrome, disseminated intravascular coagulation, shock, pancreatic encephalopathy, hypocalcemia, ketoacidosis, compartment syndrome). - Use of mechanical ventilation for more than 48 hour; 2. Inpatient treatment for acute pancreatitis. 3. Patients must meet the criteria for moderate to severe acute pancreatitis and experience one of the following conditions during hospitalization for acute pancreatitis: (1) Local complications (acute peripancreatic fluid collection, pseudocyst, acute necrotic collection, walled-off necrosis). (2) Organ failure during hospitalization (renal failure, liver failure, respiratory failure, circulatory failure, multiple organ dysfunction syndrome). (3) Other complications (sepsis, systemic inflammation reaction syndrome, disseminated intravascular coagulation, shock, pancreatic encephalopathy, hypocalcemia, ketoacidosis, compartment syndrome). (4) Use of mechanical ventilation for more than 48 hours. (5) Continuous use of vasopressor drugs for more than 48 hours. (6) Serum creatinine (Cr) >=170 µmol/L, persisting for more than 48 hours. 4. Inclusion criteria: Patients aged 18 years or older upon admission;

Exclusion criteria

Exclusion criteria: 1. Patients aged 90 years or older upon admission. 2. Chronic respiratory failure. 3. Chronic liver or kidney failure. 4. Patients who experienced sudden cardiac arrest prior to this hospitalization and underwent cardiopulmonary resuscitation (CPR). 5. Patients with hematologic malignancies and hematologic diseases. 6. Patients lacking information on age, gender, and inpatient survival. Patients without complete admission and discharge information such as Ulinastatin dosage. 7. Malignant tumors. 8. Patients who died within 48 hours of admission.

Design outcomes

Primary

MeasureTime frame
mortality rate;

Secondary

MeasureTime frame
Improvement in systemic inflammatory response;Ventilation situation;Vasoactive drug using duration;length of hospitalized stay;Improvement of kidney function;Liver function indicators;vital signs;adverse events in hematological;adverse events in digestive system;shock&anaphylactic shock;Abnormal kidney function;hemoglobinuria;

Countries

China

Contacts

Public ContactEnqiang Mao

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

maoeq@yeah.net+86 21 34187604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026