Acute PancreatitisNCT04708925
Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment
An observational study of Acute Pancreatitis, run by Meir Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- conservative versus plasmapharesis therapy
- How many people
- 29 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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. -
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- conservative versus plasmapharesis therapy
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative versus plasmapharesis therapyOther
conservative versus plasmapharesis therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: conservative versus plasmapharesis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
mortality within 28 days from ICU admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
- Investigators
- Sara Dichtwald, MD, Study chair, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708925
- Sponsor's protocol ID
- 0350-19-MMC
- Status last verified
- Apr 2022
- First submitted
- 12 Jan 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment. A Retrospective Study
- ClinicalTrials.gov ID
- NCT04708925
- Acronym / sponsor ID
- 0350-19-MMC
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A- conservative therpay | – | –hypertriglyceridemia-induced acute pancreatitis patients who recieved conservative therapy |
| group B- plasmapharesis therapy | – | Other: conservative versus plasmapharesis therapyhypertriglyceridemia-induced acute pancreatitis patients who recieved plasmapharesis therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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. -
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conservative versus plasmapharesis therapyconservative versus plasmapharesis therapy | Other | group B- plasmapharesis therapy |
Primary outcome
28-day mortality
Time frame: 28 days
mortality within 28 days from ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Dichtwald, MD study chair
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.