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CompletedNCT02622854Updated Nov 30, 2023

Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis

An interventional study of plasma exchange and conservative treatment in Acute Pancreatitis, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Acute Pancreatitis

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Keywords

  • plasma exchange
  • hypertriglyceridemia
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild acute hypertriglyceridemic pancreatitis
  • triglycerides >15 but \< 40 mmol/l

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • severe course of pancreatitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    plasma exchange

    plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides \<=10 mmol/l

    Procedure: plasma exchange

  • Active comparator
    conservative treatment

    infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l

    Drug: conservative treatment

Interventions

  • Procedureplasma exchange

    see arm description

  • Drugconservative treatment

    see arm description

    Also known as: glucose and insulin

06

What researchers measure

Primary outcomes

  1. decrease in triglycerides

    as % of starting value

    Time frame: within first 24 h after admission

Secondary outcomes

  1. time until triglycerides drop to <10 mmol/l

    expressed in days

    Time frame: by the end of hospital stay, up to 100 days

  2. highest C-reactive protein (CRP)

    Time frame: by the end of hospital stay, up to 100 days

  3. % of patients with severe pancreatitis

    Time frame: by the end of hospital stay, up to 100 days

07

Study locations

1 site
  • University Medical Centre Ljubljana, Ljubljana, Slovenia
    Ljubljana, 1000, Slovenia
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02622854
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Jakob Gubensek (MD, PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
Dec 7, 2015
Start date
Jun 2016
Primary completion
Aug 2020
Completion
Aug 2020
Last update
Nov 30, 2023

Study contacts

Jakob Gubensek, MD, PhD
principal investigator · University Medical Centre Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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