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

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.

SUBMITTER: Song X

PROVIDER: S-EPMC6582523 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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

Song Xiao X Shi Di D Cui Qinghong Q Yu Shanshan S Yang Jing J Song Priscilla P Walline Joseph J Xu Jun J Zhu Huadong H Yu Xuezhong X

Trials 20190618 1

<h4>Background</h4>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.<h4>Methods/design</h4>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 wit ...[more]

PMID: 31215460

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Dataset Information

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

Publications

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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