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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00483912
Other study ID # R04005
Secondary ID
Status Suspended
Phase N/A
First received June 7, 2007
Last updated June 7, 2007

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Device:
Molecular adsorbent recirculating system


Locations

Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
University of Tampere

Country where clinical trial is conducted

Finland, 

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