NCT02622854

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.2 years

First QC Date

November 26, 2015

Last Update Submit

November 27, 2023

Conditions

Acute Pancreatitis

Keywords

plasma exchangehypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • decrease in triglycerides

    as % of starting value

    within first 24 h after admission

Secondary Outcomes (3)

  • time until triglycerides drop to <10 mmol/l

    by the end of hospital stay, up to 100 days

  • 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

Study Arms (2)

plasma exchange

EXPERIMENTAL

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

conservative treatment

ACTIVE COMPARATOR

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

Drug: conservative treatment

Interventions

plasma exchangePROCEDURE

see arm description

plasma exchange
conservative treatmentDRUG

see arm description

Also known as: glucose and insulin
conservative treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • severe course of pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Related 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: 10.3389/fmed.2022.870067. eCollection 2022.

    PMID: 35492338RESULT

MeSH Terms

Conditions

PancreatitisHypertriglyceridemia

Interventions

Plasma ExchangeConservative TreatmentGlucoseInsulin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, OperativeHexosesMonosaccharidesSugarsCarbohydratesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jakob Gubensek, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 7, 2015

Study Start

June 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

SL(1)