Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in C-Reactive Protein (CRP)
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Predicted Severe Acute Pancreatitis
- •Enrollment within 72 hours of diagnosis
- •Ability to give informed consent
- •Age >17 years
排除标准
- •Moderate or severe congestive heart failure
- •History of seizure disorder or demyelinating disease
- •Nursing mothers
- •History of prior tuberculosis or risk factors for tuberculosis
- •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).
- •Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
- •Evidence of active or pending hemorrhage.
- •Paralytic ileus with 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 received up to a maximum of 9 doses.
干预措施: Pentoxifylline (Drug)
Placebo
Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received 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 (CRP)
时间窗: 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.
Changes in Interleukin (IL) IL-8
时间窗: baseline, Day 1, Day 3
Normal value range for IL-8 = 0 - 5 pg/ml.
Change in Tumor Necrosis Factor (TNF)-Alpha
时间窗: baseline, Day 1, Day 3
Normal value range for TNF alpha = 0 - 22 pg/ml.
Change in Interleukin (IL) IL-6
时间窗: baseline, Day 1, Day 3
Normal value range for IL-6 = 0 - 5 pg/ml.
次要结局
- Number of Subjects Who Needed an Intensive Care Unit Stay(30 days, or until dismissal, whichever came first)
- Length of Hospital Stay(30 days or until dismissal date, whichever occurs earlier)
- Length of Intensive Care Unit (ICU) Stay(30 days or until dismissal date, whichever occurs earlier)
- Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization(1 week or until dismissal date whichever occurs earlier)
- Number of Patients With Lengthy Hospital Stays(30 days or until dismissal date, whichever occurs earlier)
- Number Of Subjects With New Onset Organ Failure During Hospitalization(1 week or until dismissal date whichever occurs earlier.)
研究者
Santhi Swaroop Vege, M.D.
Principal Investigator
Mayo Clinic