Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment

NCT ID: NCT04708925

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-10-01

Brief Summary

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.

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

Conditions

Acute Pancreatitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

group A- conservative therpay

hypertriglyceridemia-induced acute pancreatitis patients who recieved conservative therapy

No interventions assigned to this group

group B- plasmapharesis therapy

hypertriglyceridemia-induced acute pancreatitis patients who recieved plasmapharesis therapy

conservative versus plasmapharesis therapy

Intervention Type: OTHER

conservative versus plasmapharesis therapy

Interventions

conservative versus plasmapharesis therapy

conservative versus plasmapharesis therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sara dichtwald

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Dichtwald, MD

Role: STUDY_CHAIR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

0350-19-MMC

Identifier Type: -

Identifier Source: org_study_id