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

November 27, 2023 updated by: Jakob Gubensek, University Medical Centre Ljubljana

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana, Ljubljana, Slovenia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • severe course of pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
see arm description
Active Comparator: conservative treatment
infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l
Drug: conservative treatment
see arm description
Other Names:
  • glucose and insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decrease in triglycerides
Time Frame: within first 24 h after admission
as % of starting value
within first 24 h after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time until triglycerides drop to <10 mmol/l
Time Frame: by the end of hospital stay, up to 100 days
expressed in days
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
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
by the end of hospital stay, up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Jakob Gubensek, MD, PhD, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimated)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiperlipPankr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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