PancreatitisNCT00484042
Activation of Polyamine Catabolism in Patients With Acute Pancreatitis
An observational study of Pancreatitis and Polyamines, run by Tampere University.
Trial summary
Background: Polyamines are essential compounds in all mammalian tissues. If tissue spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely endangered. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Polyamines
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who underwent operation
- Patients who underwent recurrent acute pancreatitis
About this study
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.
- Conditions
- Pancreatitis, Polyamines
- Keywords
- pancreatitis, polyamine, cytokine
- Medical subject headings
- Pancreatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJan 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Investigators
- Isto H Nordback, M.D., Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484042
- Sponsor's protocol ID
- R06025
- Status last verified
- Jun 2007
- First submitted
- 7 Jun 2007
- Last updated
- 8 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Polyamine Catabolism in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00484042
- Acronym / sponsor ID
- R06025
- Conditions
- Pancreatitis, Polyamines
- Keywords
- pancreatitis, polyamine, cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who underwent operation
- Patients who underwent recurrent acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isto H Nordback, M.D. principal investigator
Tampere University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis and Polyamines, run by Tampere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2007.