Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment

Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment. A Retrospective Study

Introduction: Hypertriglyceridemia is one of the etiologies of acute pancreatitis. It may cause severe multi-system disease resulting in high morbidity and mortality. There is controversy regarding the best method to treat it, which includes, among other therapies, high-dose insulin and performing plasma exchange (apheresis).

Aims: Primary outcome - Comparison of 28- day mortality between hypertriglyceridemia-induced acute pancreatitis patients who received conservative therapy versus those who received apheresis therapy. Secondary outcomes: Comparison of morbidity parameters and rate of blood triglycerides level decrease between the groups.

Materials and Methods: A retrospective study based on observational data collection, which will include all patients aged 18--99 who were admitted to the intensive care unit in 2010-2020 in the diagnosis of acute pancreatitis secondary to high blood lipids. Data will be collected from hospital files and computerized systems. Data will include demographics, admission times, ventilation days, pressor support, 28- day mortality,daily triglyceride level, medical history, APACHE-2 score, lactate level, need for dialysis, need for antibiotics and surgical intervention. The study will include 29 patients. All demographic and patient parameters will be statistically examined by a qualified statistician depending on the type of data.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: conservative versus plasmapharesis therapy

Detailed Description

Background: Hypertriglyceridemia causes 1-7% of all acute pancreatitis cases. The mechanism by which excess lipids in the blood cause pancreatitis is not entirely clear. The hypothesis is, that the enzyme lipase, which originates in the pancreas, causes increased breakdown of triglycerides into free fatty acids, which are toxic to endothelial cells and pancreatic acinary cells. In addition, excess fat in the blood increases blood viscosity and impairs blood flow to the pancreas, thus causing necrosis.

There is controversy regarding the best way to treat pancreatitis secondary to hypertriglyceridmia. In addition to fasting, intravenous fluids and analgesia, a number of methods have been used to lower blood lipids, such as heparin and insulin or plasma exchange. Performing plasma exchange causes rapid removal of lipids from the plasma, but it is not yet accepted as the treatment of choice, as there are so far no random prospective studies that have shown an advantage for this treatment method over conservative methods.

The American Society of apheresis defines plasma exchange as a Category 3 indication for the treatment of acute pancreatitis secondary to hyperlipidemia, i.e. as a treatment method whose effectiveness has not been unequivocally proven, and its use is at the discretion of the treating physician.

In the last ten years, the intensive care unit at our institution has treated 29 patients who were admitted due to hypertriglyceridemia induced acute pancreatitis. Some patients were treated conservatively, and some were treated by plasma exchange. We would like to investigate whether there was a difference in mortality rates and morbidity parameters between the groups.

Aims: The primary outcome of this study was to compare 28-days mortality rates among patients who received apheresis versus those who did not. Secondary outcomes were comparison of morbidity parameters between the groups: APACHE score, ICU and hospital length of stay, ventilation days, pressor support, need for renal replacement therapy, need for antibiotics, need for surgical of minimally invasive intervention, and rate of blood triglycerides decrease.

Materials and methods: A retrospective study among patients who were admitted to the ICU between years 2010-2020 due to hypertriglyceridemia-induced acute pancreatitis, a total of 29 cases. Data will be collected from hospital files and computer systems (Chameleon system and iMDsoft software).

Inclusion criteria: All patients aged 18-99 who were admitted to the intensive care unit in Meir medical hospital between years 2010-2020, whose cause of admission was hypertriglyceridemia-induced acute pancreatitis, defined as abdominal pain, elevated levels of amylase and lipase and blood triglyceride level above 1000 mg/dl, without any other apparent etiology of pancreatitis.

Collected data: Patient demographics and medical history including chronic pharmacologic therapy, hospital admission times, ventilation days, inotropic therapy, hemodialysis, daily blood triglyceride level, 28-day mortality, APACHE 2 score, lactate level, antibiotic therapy and need for surgical intervention. All data will be statistically analyzed according to type of data

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18-99 who were admitted to the intensive care unit in Meir medical hospital between years 2010-2020, whose cause of admission was hypertriglyceridemia-induced acute pancreatitis, defined as abdominal pain, elevated levels of amylase and lipase and blood triglyceride level above 1000 mg/dl, without any other apparent etiology of pancreatitis.

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Description

Inclusion Criteria:All patients aged 18-99 who were admitted to the intensive care unit in Meir medical hospital between years 2010-2020, whose cause of admission was hypertriglyceridemia-induced acute pancreatitis, defined as abdominal pain, elevated levels of amylase and lipase and blood triglyceride level above 1000 mg/dl, without any other apparent etiology of pancreatitis.

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Exclusion Criteria:None

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Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A- conservative therpay; hypertriglyceridemia-induced acute pancreatitis patients who recieved conservative therapy
group B- plasmapharesis therapy; hypertriglyceridemia-induced acute pancreatitis patients who recieved plasmapharesis therapy	Other: conservative versus plasmapharesis therapy; conservative versus plasmapharesis therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	mortality within 28 days from ICU admission	28 days

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Study Chair: Sara Dichtwald, MD, Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Pancreatic Diseases; Pancreatitis; Hypertriglyceridemia
• Other Study ID Numbers: 0350-19-MMC

Drug and device information, study documents

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