Wounds and Injuries

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Substance Related Disorders

Behaviors and Mental Disorders

Rare Diseases

Pancreatitis

Pancreatitis, Chronic

Gallstones

Cholelithiasis

Cholecystolithiasis

Hypertriglyceridemia

Pancreatitis, Alcoholic

Pancreatic Diseases

Gastrointestinal Diseases

Chronic Disease

Disease Attributes

Hyperlipidemias

Hyperlipoproteinemias

Dyslipidemias

Metabolic Diseases

Lipid Metabolism Disorders

Biliary Tract Diseases

Gallbladder Diseases

Calculi

Pathological Conditions, Anatomical

Alcohol-Induced Disorders

Alcohol-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Vasodilator Agents

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Anti-Arrhythmia Agents

Analgesics

Pentoxifylline

Adenosine

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Protective Agents

Radiation-Protective Agents

Antioxidants

Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

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

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

Placebo

Santhi Swaroop Vege, MD

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.

Pentoxifylline Treatment in Acute Pancreatitis (AP)

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

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

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

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

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Mayo Clinic

Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

Pentoxifylline: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits 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

Placebo 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.

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

Total

Age, Continuous

Sex: Female, Male

Hispanic/Latino

White

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

A scale of 0-5 used to predict mortality in patients with acute pancreatitis. A score of 0-2 is low mortality of less than 2%. A score of 3-5 is associated with higher mortality of more than 15%.

Bedside Index of Severity in Acute Pancreatitis (BISAP) Score

Sepsis is an infection which as evoked a systemic inflammatory response. Clinically, the Systemic Inflammatory Response Syndrome (SIRS) is identified by two or more symptoms including fever or hypothermia, tachycardia, tachypnea and change in blood leucocyte count. Measurements are made on a scale from 0 to 4, with higher scores indicating more severe failure symptoms.

Systematic Inflammatory Response Syndrome (SIRS) score on admission

Dr. Santhi Swaroop Vege

Admission (baseline)

Day 5

Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days.

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

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

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

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

Overall Study

Spots Global Cancer Trial Database for Pentoxifylline Treatment in Acute Pancreatitis (AP)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial