AGI grade-guided chaiqin chengqi decoction treatment for predicted moderately severe and severe acute pancreatitis (CAP trial): study protocol of a randomised, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial

Background: Acute pancreatitis (AP) is the common digestive disease with a potentially high risk of mortality. Traditional Chinese medicinal formula chaiqin chengqi decoction (CQCQD) has been used for the management of AP in West China Hospital for decades. CQCQD for AP (CAP) trial tests whether the administration of CQCQD will improve the efficacy of the present comprehensive treatments for predicted moderately severe and severe AP.Methods: This is a single-centre, randomised, controlled, double-blind, two-arm pragmatic clinical trial. Eligible patients with a clinical diagnosis of AP will be randomly allocated on a 1:1 basis to CQCQD or placebo control administration based on conventional standard therapy for AP. The administration of CQCQD and placebo are guided by Acute Gastrointestinal Injury (AGI) grade-based algorithm. The primary outcome measure will be the duration of respiratory failure within 28 days after onset. Secondary outcome measures include occurrence of new-onset organ failure and new-onset persistent organ failure, receipt of new organ support therapy, duration of gastrointestinal decompression, requirement of prokinetic agents, duration of fasting, incidence of local complications, requirement for drainage or necrosectomy, hospital length of stay, intensive care unit (ICU) length of stay, cumulative levels of C-reaction protein (CRP) on day 1, 2, 3, 5, 7, 14, 21, 28 after admission, in-hospital cost, all-cause mortality, five-level EuroQol five-dimensional (EQ-5D-5L) questionnaire and so on. Follow-up will be scheduled on 6, 12, and 26 weeks after enrolment.Discussion: The results of this study may provide high-quality evidence of the efficacy of CQCQD in the management of AP. Trial registration: Chictr.org.cn Registry (ChiCTR2000034325). Registered on 2 July, 2020. https://www.chictr.org.cn/showproj.aspx?proj=55591