Pentoxifylline Treatment in Acute Pancreatitis (AP)

Mayo Clinic83 enrolled

Overview

The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.

Participants were randomized to either the treatment group (Pentoxifylline medication) or the control group (Placebo). Participant took a pill orally, starting from the time of admission. Participants received a total of 9 doses over the three days of hospitalization (72 hours). Research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. The study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Pancreatitis (AP)Gallstone Pancreatitis Alcoholic Pancreatitis Trauma Acute Pancreatitis

Interventions

PentoxifyllineDRUG

Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors

PlaceboDRUG

A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion criteria * Enrollment within 72 hours of diagnosis of acute pancreatitis (AP) * Ability to give informed consent or a Legal Adult Representative (LAR) able to give informed consent for subject when needed as defined buy LAR use guidelines. * Adult subjects of age ≥18 years. Exclusion Criteria: * Moderate or severe congestive heart failure * History of seizure disorders or demyelinating disease * Nursing mothers * Pregnancy * History of prior tuberculosis or risk factors for tuberculosis * Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV) * Evidence of active hemorrhage * Paralytic ileus with severe nausea and vomiting

Outcomes

Primary Outcomes

Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.

C-reactive protein is a substance produced by the liver in response to inflammation. Normal C-RP levels are below 3.0 mg/L.Units: mg/L

Time frame: Admission (baseline), day 5

Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.

Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml

Time frame: Admission (baseline), day 5

Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.

Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: pg/ml

Time frame: Admission (baseline), day 5

Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.

IL-8 is a chemotactic factor that attracts neutrophils, basophils, and T-cells, but not monocytes. It is also involved in neutrophil activation. It is released from several cell types in response to an inflammatory stimulus. Units: pg/mL

Time frame: Admission (baseline), day 5

Pentoxifylline Treatment in Acute Pancreatitis (AP)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes