NCT00483912

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.

Trial Health

40
At Risk

Trial Health Score

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

Trial recruitment is currently suspended
Geographic Reach
1 country

1 active site

Status
suspended

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

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

PancreatitisMultiple Organ Failure

Keywords

pancreatitis, MARSsevere acute pancreatitis with early multiple organ failure

Interventions

Molecular adsorbent recirculating systemDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe acute alcoholic pancreatitis with early multiple organ failure (Sofa score \>2)

You may not qualify if:

  • If patient or his/her family member refuses, pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

PancreatitisMultiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sari Räty

    Dept. of Gastroenterology and Alimentary Tract Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Last Updated

June 8, 2007

Record last verified: 2007-06

Locations

FI(1)