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

TitleIntensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial
Authors
KeywordsHypertriglyceridemia-induced acute pancreatitis
Insulin
Plasmapheresis
Triglyceride-lowering
Issue Date2019
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2019, v. 20 n. 1, article no. 365 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/276163
ISSN
2017 Impact Factor: 2.067
2015 SCImago Journal Rankings: 1.077
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSong, X-
dc.contributor.authorShi, D-
dc.contributor.authorCui, QH-
dc.contributor.authorYu, SS-
dc.contributor.authorYang, J-
dc.contributor.authorSong, PP-
dc.contributor.authorWalline, JH-
dc.contributor.authorXu, J-
dc.contributor.authorZhu, HD-
dc.contributor.authorYu, XZ-
dc.date.accessioned2019-09-10T02:57:15Z-
dc.date.available2019-09-10T02:57:15Z-
dc.date.issued2019-
dc.identifier.citationTrials, 2019, v. 20 n. 1, article no. 365-
dc.identifier.issn1745-6215-
dc.identifier.urihttp://hdl.handle.net/10722/276163-
dc.description.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.-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/-
dc.relation.ispartofTrials-
dc.rightsTrials. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectHypertriglyceridemia-induced acute pancreatitis-
dc.subjectInsulin-
dc.subjectPlasmapheresis-
dc.subjectTriglyceride-lowering-
dc.titleIntensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial-
dc.typeArticle-
dc.identifier.emailSong, PP: songp@hku.hk-
dc.identifier.authoritySong, PP=rp02412-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s13063-019-3498-x-
dc.identifier.pmid31215460-
dc.identifier.scopuseid_2-s2.0-85067600409-
dc.identifier.hkuros302676-
dc.identifier.volume20-
dc.identifier.issue1-
dc.identifier.spagearticle no. 365-
dc.identifier.epagearticle no. 365-
dc.identifier.isiWOS:000472116500002-
dc.publisher.placeUnited Kingdom-

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