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

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Procedure: plasma exchange; Drug: conservative treatment

• Registration Number: NCT02622854
• Lead Sponsor: University Medical Centre Ljubljana

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-07
• Study Start: 2016-06
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• severe course of pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plasma exchange	plasma exchange	plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides \<=10 mmol/l
conservative treatment	conservative treatment	infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l

Primary Outcome Measures

Name	Time	Method
decrease in triglycerides	within first 24 h after admission	as % of starting value

Secondary Outcome Measures

Name	Time	Method
highest C-reactive protein (CRP)	by the end of hospital stay, up to 100 days
% of patients with severe pancreatitis	by the end of hospital stay, up to 100 days
time until triglycerides drop to <10 mmol/l	by the end of hospital stay, up to 100 days	expressed in days

Trial Locations

Locations (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia; 🇸🇮 Ljubljana, Slovenia