Study of New Biological Markers for Prediction of Severe Acute Pancreatitis

This study has been completed.
Sponsor:
Collaborators:
National University of Singapore, Singapore
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00786591
First received: November 4, 2008
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition
Acute Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Novel Biological Markers for the Prediction of Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Levels of substance P and hydrogen sulfide in blood measured 6-hourly over a time course of 3 days [ Time Frame: On admission to hospital, blood sampling will be done every 6 hours for 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Within 3 days of hospital admission ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood; Serum


Enrollment: 75
Study Start Date: June 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Pancreatitis Patients
Patients presenting with clinical features compatible with acute pancreatitis
Control
Preoperative patients going for elective cholecystectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical presentation suggestive of acute pancreatitis

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786591

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University of Singapore, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Medicine, Professor & Senior Consultant Gastroenterologist, Ho Khek Yu, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00786591     History of Changes
Other Study ID Numbers: D/05/194
Study First Received: November 4, 2008
Last Updated: December 27, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Acute pancreatitis
biological markers
substance P
hydrogen sulfide
disease severity index

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014