NCT00484042

Brief Summary

Background: Polyamines are essential compounds in all mammalian tissues. If tissue spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the other hand, our own data suggests that also in other models of acute experimental pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels. Minor changes were observed also in rats undergoing sham operation only. In addition of pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of the disease, combination of IL-6 and IL-10 at admission can predict organ failure with sensitivity of 95 %, specificity of 88 %. Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with acute pancreatitis also in the man. These changes are dependent on the severity of pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute pancreatitis compared with other intra-abdominal emergencies. The changes observed return to baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates with IL-6, IL-8, and procalcitonin, and positively with IL-10.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
Last Updated

June 8, 2007

Status Verified

June 1, 2007

First QC Date

June 7, 2007

Last Update Submit

June 7, 2007

Conditions

Keywords

pancreatitispolyaminecytokine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed as acute pancreatitis.
  • Patients who are diagnosed as either of gallstone, duodenal ulcer or bleeding, gastric ulcer or bleeding, irritable bowel syndrome, hernia, diverticulitis, retrocecal appendicitis with non-pancreatic acute abdominal pain.

You may not qualify if:

  • Patients who underwent operation
  • Patients who underwent recurrent acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Isto H Nordback, M.D.

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

January 1, 2006

Study Completion

June 1, 2007

Last Updated

June 8, 2007

Record last verified: 2007-06