Clinical trial NCT01292005: Pentoxifylline Treatment of Acute Pancreatitis
Official title: Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Pancreatitis
Keywords: pancreatitis
pancreatic necrosis
severe acute pancreatitis (SAP)
Alcoholic pancreatitis
gallstone pancreatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Ability to give informed consent
4. Age \>17 years

Exclusion Criteria:

1. Moderate or severe congestive heart failure
2. History of seizure disorder or demyelinating disease
3. Nursing mothers
4. Pregnancy
5. History of prior tuberculosis or risk factors for tuberculosis
6. Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\*, and HIV)- (\*the exception of prednisone use will be allowed to participate).
7. Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
8. Evidence of active or pending hemorrhage.
9. Paralytic ileus with vomiting

Primary outcomes:
measure: Change in C-Reactive Protein (CRP)
timeFrame: baseline, Day 1, Day 3
measure: Change in Tumor Necrosis Factor (TNF)-Alpha
timeFrame: baseline, Day 1, Day 3
measure: Change in Interleukin (IL) IL-6
timeFrame: baseline, Day 1, Day 3
measure: Changes in Interleukin (IL) IL-8
timeFrame: baseline, Day 1, Day 3
Secondary outcomes:
measure: Number Of Subjects With New Onset Organ Failure During Hospitalization
timeFrame: 1 week or until dismissal date whichever occurs earlier.
measure: Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
timeFrame: 1 week or until dismissal date whichever occurs earlier
measure: Number of Patients With Lengthy Hospital Stays
timeFrame: 30 days or until dismissal date, whichever occurs earlier
measure: Length of Hospital Stay
timeFrame: 30 days or until dismissal date, whichever occurs earlier
measure: Length of Intensive Care Unit (ICU) Stay
timeFrame: 30 days or until dismissal date, whichever occurs earlier
measure: Number of Subjects Who Needed an Intensive Care Unit Stay
timeFrame: 30 days, or until dismissal, whichever came first
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Santhi S Vege, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.