Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial

Trials. 2019 Jun 18;20(1):365. doi: 10.1186/s13063-019-3498-x.

Abstract

Background: 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.

Keywords: Hypertriglyceridemia-induced acute pancreatitis; Insulin; Plasmapheresis; Triglyceride-lowering.

Publication types

  • Clinical Trial Protocol
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Humans
  • Hypertriglyceridemia / complications*
  • Insulin / administration & dosage
  • Insulin / therapeutic use*
  • Middle Aged
  • Pancreatitis / therapy*
  • Plasmapheresis / methods*
  • Randomized Controlled Trials as Topic*
  • Research Design
  • Young Adult

Substances

  • Insulin

Associated data

  • ClinicalTrials.gov/NCT03342807