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

NCT ID: NCT02622854

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Pancreatitis

Keywords

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plasma exchange hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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plasma exchange

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

Group Type EXPERIMENTAL

plasma exchange

Intervention Type PROCEDURE

see arm description

conservative treatment

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

Group Type ACTIVE_COMPARATOR

conservative treatment

Intervention Type DRUG

see arm description

Interventions

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plasma exchange

see arm description

Intervention Type PROCEDURE

conservative treatment

see arm description

Intervention Type DRUG

Other Intervention Names

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glucose and insulin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* severe course of pancreatitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Jakob Gubensek

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jakob Gubensek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type RESULT
PMID: 35492338 (View on PubMed)

Other Identifiers

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HiperlipPankr

Identifier Type: -

Identifier Source: org_study_id