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pancreatitis: Albumindialysis in Acute Pancreatitis

Sponsor
Tampere University (Other)
Overall Status
Suspended
CT.gov ID
NCT00483912
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Molecular adsorbent recirculating system
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Official Title:
Molecular Adsorbent Recirculating System (MARS) in Severe Acute Pancreatitis

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere University Hospital Tampere Finland 33521

    Sponsors and Collaborators

    • Tampere University

    Investigators

    • Study Chair: Sari Räty, Dept. of Gastroenterology and Alimentary Tract Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00483912
    Other Study ID Numbers:
    • R04005
    First Posted:
    Jun 8, 2007
    Last Update Posted:
    Jun 8, 2007
    Last Verified:
    Jun 1, 2007
    Keywords provided by , ,
    pancreatitis, MARS
    severe acute pancreatitis with early multiple organ failure
    Additional relevant MeSH terms:
    Pancreatitis
    Multiple Organ Failure

    Study Results

    No Results Posted as of Jun 8, 2007