Effect Of Ulinastatin As An Auxillary Drug In Reducing Mortality And Morbidity In Severe Acute Pancreatitis – A Randomised Control Open Labelled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduce the morbidity rate in form of abdominal pain and number of days stayed in hospital
研究概览
简要总结
After obtaining Institutional scientific committee and ethical committee clearance, CTRI registration, informed consent written in their own language will be obtained from all the patients.
Patients found eligible as per inclusion criteria were offered to participate in the study.
A proforma was filled for each patient to record.
Patients will be randomized into two groups by alloting random numbers
Group A: subjects in this group will receive ulinastatin + standard treatment as per IAP protocol. Subjects in group a will receive ulinastatin administered by iv infusion in a dose of 200,000 iu in 100ml of d5 or ns administered over 1 hour twice daily (12 ± 2 hours apart) for 5 days (days 1 to day 5). A minimum of 6 doses should have been administered to the subject to be eligible for efficacy analysis.
Group B: subjects in this group will receive only standard treatment as per IAP protocol.
Various parameters including mortality rates, onset of new organ failure, local complications, ICU and hospital stay, biomarker levels, and pain scores were assessed to understand the potential benefits of ulinastatin treatment compared to standard therapy alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical Presentation: Presence of any two of the following three criteria: A.Upper abdominal pain characteristic of acute pancreatitis (acute onset of persistent, severe, epigastric pain often radiating to the back).
- •B.Serum amylase and/or lipase levels three times the upper limit of normal (amylase: 40-140 units/litre, lipase: 0-160 units/litre).
- •C.Characteristic findings of acute pancreatitis on CT or ultrasonography.
- •Diagnosis of moderately severe or severe acute pancreatitis, based on the revised Atlanta classification for acute pancreatitis.
- •Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis.
- •Pancreatitis with multiorgan dysfunction.
排除标准
- •1.Exclusion of cases with mild pancreatitis, defined by the absence of organ failure, local, or systemic complications.
- •2.Pregnancy or Nursing.
- •3.Recent Participation in Clinical Studies.
- •4.Pancreatic Cancer.
- •5.Non-Participation Willingness.
结局指标
主要结局
Reduce the morbidity rate in form of abdominal pain and number of days stayed in hospital
时间窗: Assessed on day 0, day 3, day 28 or at discharge
次要结局
- Reduce the case fatality rate(Assessed from day 0 to day 28 or discharge & once at day 90)
研究者
Abishek Prasenaa A
SRMMCH and RC Kattankulathur campus