Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis

Completed

• Conditions: Hypertriglyceridemia; Pancreatitis

• Registration Number: NCT05096455
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assess benefit of plasmapheresis	Day 28	Assess benefit of plasmapheresis for patients admitted in ICU for HTG-associated PA
Length of hospitalization	Day 28	Describe length of stay in ICU and on hospital for patients admitted in ICU for HTG-associated PA
Use of organ support	Day 28	Describe use of organ supports (vasopressors, extra-renal dialysis and mechanical ventilation)

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France