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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis; Hypertriglyceridemia

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient hospitalized with severe acute pancreatitis of hypertriglycemic origin admitted to the ICU between January 2010 and January 2020.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 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.	Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: ICU
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Pancreatic Diseases; Pancreatitis; Hypertriglyceridemia
• Other Study ID Numbers: LOCAL/2021/SB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No