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

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
plasma exchange
conservative treatment
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring plasma exchange, hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • severe course of pancreatitis

Sites / Locations

  • University Medical Centre Ljubljana, Ljubljana, Slovenia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

plasma exchange

conservative treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

decrease in triglycerides
as % of starting value

Secondary Outcome Measures

time until triglycerides drop to <10 mmol/l
expressed in days
highest C-reactive protein (CRP)
% of patients with severe pancreatitis

Full Information

First Posted
November 26, 2015
Last Updated
November 2, 2020
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02622854
Brief Title
Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis
Official Title
Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
plasma exchange, hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plasma exchange
Arm Type
Experimental
Arm Description
plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides <=10 mmol/l
Arm Title
conservative treatment
Arm Type
Active Comparator
Arm Description
infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l
Intervention Type
Procedure
Intervention Name(s)
plasma exchange
Intervention Description
see arm description
Intervention Type
Drug
Intervention Name(s)
conservative treatment
Other Intervention Name(s)
glucose and insulin
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
decrease in triglycerides
Description
as % of starting value
Time Frame
within first 24 h after admission
Secondary Outcome Measure Information:
Title
time until triglycerides drop to <10 mmol/l
Description
expressed in days
Time Frame
by the end of hospital stay, up to 100 days
Title
highest C-reactive protein (CRP)
Time Frame
by the end of hospital stay, up to 100 days
Title
% of patients with severe pancreatitis
Time Frame
by the end of hospital stay, up to 100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild acute hypertriglyceridemic pancreatitis triglycerides >15 but < 40 mmol/l Exclusion Criteria: pregnancy severe course of pancreatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Gubensek, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana, Ljubljana, Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35492338
Citation
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.
Results Reference
derived

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

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