Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.
研究概览
简要总结
The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
Pentoxifylline
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.
干预措施: Pentoxifylline (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.
时间窗: Admission (baseline), day 5
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
Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.
时间窗: Admission (baseline), day 5
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
Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.
时间窗: Admission (baseline), day 5
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
Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.
时间窗: Admission (baseline), day 5
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
次要结局
未报告次要终点