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

Xiao Song, Di Shi, Qinghong Cui, Shanshan Yu, Jing Yang, Priscilla Song, Joseph Walline, Jun Xu, Huadong Zhu, Xuezhong Yu, Xiao Song, Di Shi, Qinghong Cui, Shanshan Yu, Jing Yang, Priscilla Song, Joseph Walline, Jun Xu, Huadong Zhu, Xuezhong Yu

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.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) schedule of enrolment, intervention and assessments. *Baseline variables: age, gender, body mass index (BMI), diet, history of alcoholism, comorbidity, family history of hypertriglyceridemia or hypertriglyceridemia-induced acute pancreatitis (HTG-AP). ^Primary outcome: triglyceride (TG) level #Secondary outcome: ICU- and hospital length of stay (LOS), 28-day mortality, HTG-AP severity scores, incidence of hypoglycemia, HTG-AP complications, and cost-effectiveness

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Source: PubMed

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