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NCT02622854 Clinical Trial

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

Acute Pancreatitis Clinical Trial

Official title:
Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02622854
Other study ID # HiperlipPankr
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date August 2020

Study information
Verified date November 2023
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - mild acute hypertriglyceridemic pancreatitis - triglycerides >15 but < 40 mmol/l Exclusion Criteria: - pregnancy - severe course of pancreatitis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• plasma exchange
see arm description
Drug:
• conservative treatment
see arm description

Locations
Country Name City State
Slovenia University Medical Centre Ljubljana, Ljubljana, Slovenia Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

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: — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary decrease in triglycerides as % of starting value within first 24 h after admission
Secondary time until triglycerides drop to <10 mmol/l expressed in days by the end of hospital stay, up to 100 days
Secondary highest C-reactive protein (CRP) by the end of hospital stay, up to 100 days
Secondary % of patients with severe pancreatitis by the end of hospital stay, up to 100 days
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