PancreatitisTRIPANNCT05096455
Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis
An observational study of Pancreatitis and Hypertriglyceridemia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Hypertriglyceridemia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient hospitalized with severe acute pancreatitis of hypertriglycemic origin admitted to the ICU between January 2010 and January 2020.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study
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.
Read more
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.
- Conditions
- Pancreatitis, Hypertriglyceridemia
- Keywords
- ICU
- Medical subject headings
- Pancreatitis, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe acute pancreatitis | Patients 18 years of age or older admitted to intensive care or resuscitation for severe acute pancreatitis (AP) with hypertriglyceridemia (HTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (3)
Length of hospitalization
Describe length of stay in ICU and on hospital for patients admitted in ICU for HTG-associated PA
Measured: Day 28
Use of organ support
Describe use of organ supports (vasopressors, extra-renal dialysis and mechanical ventilation)
Measured: Day 28
Assess benefit of plasmapheresis
Assess benefit of plasmapheresis for patients admitted in ICU for HTG-associated PA
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephanie Bulyez, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096455
- Sponsor's protocol ID
- LOCAL/2021/SB-01
- Acronym
- TRIPAN
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 27 Oct 2021
- 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 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05096455
- Acronym / sponsor ID
- TRIPAN / LOCAL/2021/SB-01
- Conditions
- Pancreatitis, Hypertriglyceridemia
- Keywords
- ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Oct 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe acute pancreatitis | – | –Patients 18 years of age or older admitted to intensive care or resuscitation for severe acute pancreatitis (AP) with hypertriglyceridemia (HTG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient hospitalized with severe acute pancreatitis of hypertriglycemic origin admitted to the ICU between January 2010 and January 2020.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality at Day 28
Time frame: 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.
3 secondary outcomes
Length of hospitalization
Time frame: Day 28
Use of organ support
Time frame: Day 28
Assess benefit of plasmapheresis
Time frame: Day 28
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 27 Oct 2021.
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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.
stephanie Bulyez, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Pancreatitis and Hypertriglyceridemia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 6 inclusion and 0 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 27 Oct 2021. 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 France. 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?
Mortality at Day 28 (time frame: Day 28). 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 27 Oct 2021.