Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
Brief Summary:
This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN.
The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.
Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission.
Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.