Clinical Trial: Pentoxifylline Treatment of Acute Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Mayo Clinic

Current Primary Outcome:

• Change in C-Reactive Protein (CRP) [ Time Frame: baseline, Day 1, Day 3 ]
  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.
• Change in Tumor Necrosis Factor (TNF)-Alpha [ Time Frame: baseline, Day 1, Day 3 ]
  Normal value range for TNF alpha = 0 - 22 pg/ml.
• Change in Interleukin (IL) IL-6 [ Time Frame: baseline, Day 1, Day 3 ]
  Normal value range for IL-6 = 0 - 5 pg/ml.
• Changes in Interleukin (IL) IL-8 [ Time Frame: baseline, Day 1, Day 3 ]
  Normal value range for IL-8 = 0 - 5 pg/ml.

Original Primary Outcome:

• Changes in CRP [ Time Frame: 1 week ]
  This primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
• Changes in TNF-alpha [ Time Frame: 1 week ]
  The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
• Changes in IL-6 [ Time Frame: 1 week ]
  The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.
• Changes in IL-8 [ Time Frame: 1 week ]
  The primary objective of our research is to determine whether inhibition of the TNF-pathway by Pentoxifylline reduces inflammatory markers in severe AP.

Current Secondary Outcome:

• 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 [ Time Frame: 30 days or until dismissal date, whichever occurs earlier ]
  "Lengthy" was defined as either greater than 4 days or greater than 10 days.
• Length of Hospital Stay [ Time Frame: 30 days or until dismissal date, whichever occurs earlier ]
• 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 ]

Original Secondary Outcome:

• Development of organ failure during hospitalization [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Development of pancreatic necrosis during hospitalization. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Death during hospitalization. [ Time Frame: 1week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Need for radiologic, endoscopic and/or surgical intervention. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Length of hospital stay and the need for intensive care. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Development of serious infection: Culture positive infections in pancreatic/peripancreatic, blood stream, urine or clinical/radiological evidence of pneumonia after initiation of Pentoxifylline. [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.
• Adverse events like hemorrhage and and the most common side effects listed in the drug package insert in the treatment group [ Time Frame: 1 week or until dismissal date whichever occurs earlier. ]
  This secondary objective of our research is to determine if Pentoxifylline is safe, beneficial and well-tolerated in patients with severe AP.

Information By: Mayo Clinic

Dates:
Date Received: October 19, 2010
Date Started: April 2009
Date Completion:
Last Updated: September 14, 2016
Last Verified: March 2016