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TRIPAN: Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT05096455
Collaborator
(none)
100
Enrollment
1
Location
132
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute pancreatitis (AP) is a one of the potentially life-threatening complication of severe hypertriglyceridemia (HTG), with mortality around to 30%.

HTG-associated PA and their complications management has to be the same as the other pancreatitis, but they are associated with the worse clinical outcomes. Triglycerides levels are correlated with the risk of pancreatitis and severity.

Therapeutic plasma exchange (TPE) could provide positive effects in reducing triglyceridemia plasma levels during the acute phase of HTG-AP, and in prevention of recurrence. There is currently no difference about mortality in studies. Some authors have recommended its use only in severe HTG-AP and have precised the need of early initiation to have positive results.

Despite such promising findings from studies, the effects of therapeutic plasma exchange on HTG-associated PA have never been specifically assessed and its benefits in critically ill patients with AP remains uncertain.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study
    Actual Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    severe acute pancreatitis

    Patients 18 years of age or older admitted to intensive care or resuscitation for severe acute pancreatitis (AP) with hypertriglyceridemia (HTG)

    Outcome Measures

    Primary Outcome Measures

    1. Mortality at Day 28 [Day 28]

      Assess the factors on admission associated with the prognosis of patients admitted in ICU for HTG-associated PA. Factors associated with death at D28 will be considered individually for entry into a multivariate model. The following variables of interest will be tested in the model: SOFA score, triglyceride level at admission, obesity.

    Secondary Outcome Measures

    1. Length of hospitalization [Day 28]

      Describe length of stay in ICU and on hospital for patients admitted in ICU for HTG-associated PA

    2. Use of organ support [Day 28]

      Describe use of organ supports (vasopressors, extra-renal dialysis and mechanical ventilation)

    3. Assess benefit of plasmapheresis [Day 28]

      Assess benefit of plasmapheresis for patients admitted in ICU for HTG-associated PA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18 years

    • Admission in ICU for acute pancreatitis associated with HTG

    Exclusion Criteria : Patient without norepinephrine or missing data.

    • Acute pancreatitis without HTG

    • Patient already include in this study

    • Patient opposed to use of his data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Principal Investigator: stephanie Bulyez, MD, PhD, Centre Hospitalier Universitaire de Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT05096455
    Other Study ID Numbers:
    • LOCAL/2021/SB-01
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Oct 27, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    ICU
    Additional relevant MeSH terms:
    Pancreatitis
    Hypertriglyceridemia

    Study Results

    No Results Posted as of Oct 27, 2021