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临床试验/NCT00786591
NCT00786591已完成不适用

Clinical Evaluation of Novel Biological Markers for the Prediction of Severe Acute Pancreatitis

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Levels of substance P and hydrogen sulfide in blood measured 6-hourly over a time course of 3 days

研究概览

简要总结

Acute pancreatitis refers to inflammation of the pancreas and is associated with sudden onset of severe abdominal pain, often accompanied by transient systemic manifestations, including fever. In the majority of cases, the inflammatory process is self limiting and patient recovers uneventfully; however, in about 20% to 30% of the cases, a protracted clinical course ensues and the disease may progress to a severe necrotizing form, often triggering a systemic inflammatory response syndrome during which time, acute respiratory distress syndrome, renal failure, shock, and disseminated intravascular coagulation may occur. In the worst sequelae, multiple organ dysfunctions may follow and death supervene. The clinical outcome of patients suffering from severe acute pancreatitis depends to a great extent on the early diagnosis and prediction of severity and timely therapeutic intervention to prevent local and systemic complications. However, the course of the disease is often difficult to predict from the outset. Currently, there is still no single clinical or laboratory test that can be considered the "gold standard" for diagnosis and/or assessment of severity of acute pancreatitis. For a disease that may progress rapidly without apparent sign, the ideal marker for the prediction of disease severity in a patient would be one that is measurable rapidly and easily, besides being able to fulfill all the other criteria required of a good biological marker. To identify such a potential marker for acute pancreatitis requires understanding of the pathophysiological process underlying the rapid progression of a fulminant course of the disease. Although much remains to be elucidated, recent studies in animals have suggested that inflammatory mediators substance P and hydrogen sulfide may play critical roles. This study will evaluate if inflammatory mediators substance P and hydrogen sulfide are upregulated early on in the disease process, and if the levels of their elevation predict disease severity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient should fulfill all of the following criteria:
  • The subject should be at least 18 years of age.
  • Clinical features compatible with acute pancreatitis.
  • First symptoms of acute pancreatitis not more than 72 hours before enrolment.
  • Serum amylase level above 480 U/dl (normal 60-160 U/dl or 2-hour urinary amylase greater than 1120 U (normal 280 U).
  • Serum lipase levels greater than 2 U (normal < 1 U).
  • Patient has signed consent form regarding participation in the study.

排除标准

  • The patient should not present any of the following criteria:
  • Symptoms of acute pancreatitis present for more than 72 hours
  • Clinical evidence of sepsis or other inflammatory diseases.
  • Clinical evidence of disorders/disease known to affect endogenous regulation of substance P, e.g. asthma, immune-complex-mediated lung injury, arthritis.
  • Age under 18 years
  • Pregnancy

结局指标

主要结局

Levels of substance P and hydrogen sulfide in blood measured 6-hourly over a time course of 3 days

时间窗: On admission to hospital, blood sampling will be done every 6 hours for 3 days

次要结局

  • Disease severity index derived from: (i) Ranson score; (ii) Acute Physiology and Chronic Health Evaluation (APACHE) II scores; (iv) Glasgow and (v) Multi-Organ System Failure (MOSF) Score(Within 3 days of hospital admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Medicine

Professor & Senior Consultant Gastroenterologist, Ho Khek Yu

National University Hospital, Singapore

研究点 (1)

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