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OpenTrials
Completed

NCT Number: NCT05096455

Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality at Day 28

    Time frame: 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 outcomes

  1. Length of hospitalization

    Time frame: 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

    Time frame: Day 28

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

  3. Assess benefit of plasmapheresis

    Time frame: Day 28

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study

Acronym: TRIPAN

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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