Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial
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AbstractBackground
It is widely agreed that triglyceride (TG)-lowering therapy is imperative in early hypertriglyceridemia-induced acute pancreatitis (HTG-AP). Intravenous insulin with or without heparin, and plasmapheresis are available regimens. However, there is no consensus on first-line therapy.

Methods/design
The Bi-TPAI trial is a multicenter, parallel group, randomized, controlled, non-inferiority trial in patients with early HTG-AP. The Bi-TPAI trial will include 220 patients with HTG-AP from 17 large tertiary hospitals in China. Patients assigned to the intensive insulin group will be administered an intravenous continuous infusion of regular human insulin at a rate of 0.1 units/kg·h and up to 0.3 units/kg·h. Patients allocated to the plasmapheresis group will receive standard-volume plasmapheresis. The primary endpoint is the time it takes for the TG level to reduce to 500 mg/dl. The secondary endpoints are ICU and hospital lengths of stay, 28-day mortality, severity of HTG-AP, incidence of hypoglycemia, HTG-AP complications, and cost-effectiveness.

Discussion
The Bi-TPAI trial will prove that intensive insulin therapy is non-inferior to plasmapheresis. Intensive insulin therapy should be an effective, safe, available, and cheaper triglyceride-lowering therapy for hypertriglyceridemia-induced acute pancreatitis.

Trial registration
ClinicalTrials.gov, NCT03342807. Registered on 5 Nov 2017.
All Author(s) ListSong X, Shi D, Cui QH, Yu SS, Yang J, Song P, Walline J, Xu J, Zhu HD, Yu XZ
Journal nameTrials
Year2019
Month6
Day18
Volume Number20
PublisherBMC
Article number365
ISSN1745-6215
LanguagesEnglish-United Kingdom
KeywordsHypertriglyceridemia-induced acute pancreatitis, Insulin, Plasmapheresis, Triglyceride-lowering
Web of Science Subject CategoriesMedicine, Research & Experimental;Research & Experimental Medicine

Last updated on 2020-24-05 at 23:34