Study on Tocilizumab in Patients with Predicted Severe Acute Pancreatitis (STOP-SAP) for Preventing Progression to Actual Severe Acute Pancreatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Phase 3
Not yet recruiting
- Conditions
- predicted severe acute pancreatitissevere acute pancreatitis
- Registration Number
- TCTR20210302008
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Predicted severe acute pancreatitis at admission, defined by at least one of
1. BISAP equal or more than 3
2. End organ failures by Modified Marshall scoring system
Exclusion Criteria
ALT or AST > 5x UNL
onset of pancreatitis more than 72 hours
severe acute pancreatitis at admission
Severe cholangitis
Chronic pancreatitis
Cardiomyopathy (EF < 30) or active heart failure
Active/uncontrolled infection
Terminal cancer
Hypersensitivity
Previous treatment with tocilizumab
Pregnancy
Inability or unwillingness to provide consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Actual severe acute pancreatitis 48 hour after admission Defined by Revised Atlanta Classification
- Secondary Outcome Measures
Name Time Method mortality rate in admission death,adverse event rate in admission adverse event rate,length of hospital stay in admission day,length of ICU stay in admission day,local complication in admission Defined by Revised Atlanta classification