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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

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