The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.
Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in. You will be put into either the treatment group or the control group. * The treatment group will receive a drug called pentoxifylline * The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours). When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Mayo Clinic
Rochester, Minnesota, United States
Change in C-Reactive Protein (CRP)
C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.
Time frame: baseline, Day 1, Day 3
Change in Tumor Necrosis Factor (TNF)-Alpha
Normal value range for TNF alpha = 0 - 22 pg/ml.
Time frame: baseline, Day 1, Day 3
Change in Interleukin (IL) IL-6
Normal value range for IL-6 = 0 - 5 pg/ml.
Time frame: baseline, Day 1, Day 3
Changes in Interleukin (IL) IL-8
Normal value range for IL-8 = 0 - 5 pg/ml.
Time frame: baseline, Day 1, Day 3
Number Of Subjects With New Onset Organ Failure During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier.
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier
Number of Patients With Lengthy Hospital Stays
"Lengthy" was defined as either greater than 4 days or greater than 10 days.
Time frame: 30 days or until dismissal date, whichever occurs earlier
Length of Hospital Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
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Length of Intensive Care Unit (ICU) Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
Number of Subjects Who Needed an Intensive Care Unit Stay
Time frame: 30 days, or until dismissal, whichever came first