Randomization and masking
shock, abdominal pain, cholangitis
SHOCK, BLIND, CHOLANGITIS
The TG18 (Tokyo Guidelines 2018) classification grades the severity of cholangitis and guides clinical decisions in individual patients based on inflammatory markers, including WBC and CRPPatients with mild cholangitis were randomized (1:1) to receive intravenous injection of CSTS or MEPM. Patients with severe cholangitis were randomized (1:1) to receive intravenous MEPM or a combination of intravenous MEPM and immunoglobulin (MEPM+IVIG). The randomization sequence was generated using a web-based application (Microsoft Office Excel 2013, Microsoft Corporation). The randomization schedule was designed before the first patient was enrolled and did not change throughout the study. Participants, site staff, and treating physicians were not masked to treatment allocation. The random assignment sequences were concealed in the airtight envelopes. When an infant qualified for enrollment, the appropriate airtight envelope with the unique random number was given to the parent. The investigator would then open the envelope and obtain the detailed intervention information. In addition, to better control for bias, the clinical reviewers and the statistician were all blind to the allocation sequence.After randomization, blood cultures and antimicrobial susceptibility testing were obtained prior to empiric antibiotic treatment. Antibiotics would be adjusted under the following conditions: different effective antibiotics as determined by antimicrobial susceptibility testing; CSTS would be changed to MEPM with or without IVIG if there was no initial rapid reduction in WBC and CRP; clinical deterioration, including shock, and persistent or worsening abdominal pain. The study would be stopped under these circumstances.