Selective depletion of C-reactive protein by means of therapeutic apheresis (CRP-apheresis) in acute pancreatitis
Not Applicable
Recruiting
- Conditions
- K85.80
- Registration Number
- DRKS00014265
- Lead Sponsor
- Pentracor GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
• Acute pancreatitis according to the S3 Guideline Pancreatitis of the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS)
• Moderate or severe acute pancreatitis according to the Atlanta Classification of 2013
• CRP = 100 mg/l up to 24 hours after symptom onset or CRP = 150 mg/l if the onset of symptoms was more than 24 hours ago
• Written informed consent
Exclusion Criteria
• Age < 18 or = 80 years
• Positive harmless acute pancreatitis score (HAPS)
• Therapy-refractory shock
• Pregnancy or breastfeeding
• Participation in other interventional trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of CRP-apheresis in acute pancreatitis (incidence of expected and unexpected adverse effects of CRP-apheresis)
- Secondary Outcome Measures
Name Time Method Course of the disease (Determination of laboratory parameters/diagnostic biomarkers/scores:<br>• ALT, AST, gamma-GT, alkaline phosphatase, bilirubin, pro-calcitonin, CRP, leukocytes, hematocrit, creatinine, serum urea, eGFR, urine excretion<br>• Modified CT severity index (MCTSI)<br>• SAPS (Simplified Acute Physiology Score)<br>• TISS (Therapeutic Intervention Scoring System)<br>• BISAP score<br>• Hospitalization <br>• Presence and infection rate of pancreatic necrosis)