Ulinastatin in Severe Acute Pancreatitis

• Status: Suspended
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Techpool Bio-Pharma Co., Ltd.
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Peking Union Medical College Hospital; The First Affiliated Hospital with Nanjing Medical University; The first clinical college of harbin medical university; West China Hospital; Wuhan Union Hospital, China
• Treatments: Pharmaceutical Solutions; Trypsin Inhibitors; Urinastatin

Criteria

Inclusion Criteria:

• Clinical diagnosis of severe acute pancreatitis , severe acute pancreatitis adapted from the Atlanta classification:

Early Prognostic Signs: Ramson signs ≥3, APACHE II score ≥8 Organ Failure and/or Local Complications: Necrosis, Abscess, Pseudocyst;

• Admission within 72h after onset of symptoms of pancreatitis

• 18-70 years old

• Signed the informed consent form

Exclusion Criteria:

• Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis

• pre existing heart dysfunction or NYHA classification score above III

• pregnancy or lactation

• Allergy for ulinastatin

• Received an investigational drug or device within 90 days prior to entering study

• serious mentally-ill patients including dementia

• On the verge of death (estimated to be mortal in 12h).