Acute PancreatitisNCT02622854
Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis
A study testing plasma exchange and conservative treatment in people with Acute Pancreatitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- plasma exchange and conservative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSlovenia
- Study dates
- Jun 2016to Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- mild acute hypertriglyceridemic pancreatitis
- triglycerides >15 but < 40 mmol/l
Who cannot join
- pregnancy
- severe course of pancreatitis
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Ljubljana, Ljubljana, Slovenia
Ljubljana, 1000
About this study
Official title: Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides
To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides
- Conditions
- Acute Pancreatitis
- Being tested
- plasma exchange, conservative treatment
- Keywords
- plasma exchange, hypertriglyceridemia
- Medical subject headings
- Pancreatitis, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma exchangeProcedure or surgery
see arm description
conservative treatmentDrug
Also called glucose and insulin
see arm description
| Study group | Role | What they receive |
|---|---|---|
| plasma exchange | Experimental | plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides <=10 mmol/l Receives: Procedure: plasma exchange |
| conservative treatment | Active comparator | infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l Receives: Drug: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in triglycerides
as % of starting value
Measured: within first 24 h after admission
Secondary outcomes (3)
time until triglycerides drop to <10 mmol/l
expressed in days
Measured: by the end of hospital stay, up to 100 days
highest C-reactive protein (CRP)
Measured: by the end of hospital stay, up to 100 days
% of patients with severe pancreatitis
Measured: by the end of hospital stay, up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Gubensek, University Medical Centre Ljubljana
- Investigators
- Jakob Gubensek, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622854
- Sponsor's protocol ID
- HiperlipPankr
- Status last verified
- Nov 2023
- First submitted
- 26 Nov 2015
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Gubensek J, Andonova M, Jerman A, Persic V, Vajdic-Trampuz B, Zupunski-Cede A, Sever N, Plut S. Comparable Triglyceride Reduction With Plasma Exchange and Insulin in Acute Pancreatitis - A Randomized Trial. Front Med (Lausanne). 2022 Apr 12;9:870067. doi: 10.3389/fmed.2022.870067. eCollection 2022.
PubMed 35492338
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT02622854
- Acronym / sponsor ID
- HiperlipPankr
- Conditions
- Acute Pancreatitis
- Keywords
- plasma exchange, hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 7 Dec 2015 (estimated)
- 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.
To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plasma exchange | Experimental | Procedure: plasma exchangeplasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides <=10 mmol/l |
| conservative treatment | Active comparator | Drug: conservative treatmentinfusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild acute hypertriglyceridemic pancreatitis
- triglycerides >15 but < 40 mmol/l
Key exclusion criteria (2 listed)
- pregnancy
- severe course of pancreatitis
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 |
|---|---|---|
| plasma exchangesee arm description | Procedure or surgery | plasma exchange |
| conservative treatmentAlso: glucose and insulinsee arm description | Drug | conservative treatment |
Primary outcome
decrease in triglycerides
Time frame: within first 24 h after admission
as % of starting value
3 secondary outcomes
time until triglycerides drop to <10 mmol/l
Time frame: by the end of hospital stay, up to 100 days
highest C-reactive protein (CRP)
Time frame: by the end of hospital stay, up to 100 days
% of patients with severe pancreatitis
Time frame: by the end of hospital stay, up to 100 days
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 30 Nov 2023.
- Results publication: PubMed 35492338Gubensek J, Andonova M, Jerman A, Persic V, Vajdic-Trampuz B, Zupunski-Cede A, Sever N, Plut S. Comparable Triglyceride Reduction With Plasma Exchange and Insulin in Acute Pancreatitis - A Randomized Trial. Front Med (Lausanne). 2022 Apr 12;9:870067. doi: 10.3389/fmed.2022.870067. eCollection 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.
Jakob Gubensek, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma exchange and conservative treatment in people with Acute Pancreatitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 2 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 30 Nov 2023. 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 Slovenia. 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?
decrease in triglycerides (time frame: within first 24 h after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622854, which also lists 1 linked publication.
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 30 Nov 2023.