Pancreatitis Clinical Trial
— pancreatitisOfficial title:
Molecular Adsorbent Recirculating System (MARS) in Severe Acute Pancreatitis
NCT number | NCT00483912 |
Other study ID # | R04005 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | June 7, 2007 |
Last updated | June 7, 2007 |
Verified date | June 2007 |
Source | University of Tampere |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Social and Heath Ministry |
Study type | Interventional |
The incidence of acute pancreatitis has been doubled during last three decades in Finland. Alcohol is the main cause of acute pancreatitis in Finland accounting for 70 % of cases. Although the mortality of acute pancreatitis has been decreased it still appears and especially early multiple organ failure is the main cause of all deaths. Multiple organ failure in the early course of the disease is thought to be caused by the release of cytokines. Molecular adsorbent recirculating system (MARS) has shown to decrease mortality in acute alcohol hepatitis and paracetamol intoxication. Also it has been shown to improve kidney function due to hypoperfusion and tubulus necrosis and overrule decrease mortality in patients with multiple organ failure due to different reasons. A part of patients with acute alcoholic pancreatitis may have so-called fat liver already on admission. It has been shown that the highest mortality is especially associated those with early liver and kidney failure. MARS treatment has never earlier been used in the patients with acute alcoholic pancreatitis and early organ failure. In this study we randomize patients with acute alcoholic pancreatitis and early multiple organ failure (Sofa score>2) to two groups: 1) Standard pancreatitis treatment in intensive care unit and 2) Standard pancreatitis treatment in intensive care unit with 5 MARS sessions.
Status | Suspended |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Severe acute alcoholic pancreatitis with early multiple organ failure (Sofa score >2) Exclusion Criteria: - If patient or his/her family member refuses, pregnancy. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
University of Tampere |
Finland,
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