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

替代計量分析
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其它資訊
摘要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.
著者Song X, Shi D, Cui QH, Yu SS, Yang J, Song P, Walline J, Xu J, Zhu HD, Yu XZ
期刊名稱Trials
出版年份2019
月份6
日期18
卷號20
出版社BMC
文章號碼365
國際標準期刊號1745-6215
語言英式英語
關鍵詞Hypertriglyceridemia-induced acute pancreatitis, Insulin, Plasmapheresis, Triglyceride-lowering
Web of Science 學科類別Medicine, Research & Experimental;Research & Experimental Medicine

上次更新時間 2020-29-11 於 23:17