Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04708925 |
| Other study ID # |
0350-19-MMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Meir Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
