• Lu Ke, Jing Zhou, Wenjian Mao, Tao Chen, Yin Zhu, Xinting Pan, Hong Mei, Vikesh Singh, James Buxbaum, Gordon Doig, Chengjian He, Weili Gu, Weihua Lu, Shumin Tu, Haibin Ni, Guoxiu Zhang, Xiangyang Zhao, Junli Sun, Weiwei Chen, Jingchun Song, Min Shao, Jianfeng Tu, Liang Xia, Wenhua He, Qingyun Zhu, Kang Li, Hongyi Yao, Jingyi Wu, Long Fu, Wendi Jiang, He Zhang, Jiajia Lin, Baiqiang Li, Zhihui Tong, John Windsor, Yuxiu Liu, Weiqin Li, and Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG).
• Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.
• Intensive Care Med. 2022 Jul 1; 48 (7): 899909899-909.

PurposeInfected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP.MethodsWe conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission.ResultsA total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).ConclusionThe immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.

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