Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis
Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 1, 2022
October 1, 2022
1.8 years
April 6, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
%triglyceride reduction
change in triglycerides, expressed as % of initial value
after 18 hours of treatment
Secondary Outcomes (1)
incidence of hypoglycemia
during treatment with insulin, up to day 5
Study Arms (2)
insulin
EXPERIMENTALstandard management
PLACEBO COMPARATORInterventions
5% glucose in 0.9% NaCl with 4 IU of short acting insulin per 500 ml added, infused at a rate determined by the treating physician, treatment duration: 18 hours
infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours
Eligibility Criteria
You may qualify if:
- acute pancreatitis
- triglycerides \> 15 mmol/l
You may not qualify if:
- diabetes on peroral therapy or insulin
- blood glucose \> 11 mmol/l
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 6, 2022
First Posted
August 4, 2022
Study Start
November 1, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request