Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis

Hypertriglyceridemia Clinical Trial

— TRIPAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096455
• Other study ID #: LOCAL/2021/SB-01
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Pancreatitis

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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