Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial

Purpose Infected 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-enhanc...

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Bibliographic Details
Published in:Intensive care medicine 2022-07, Vol.48 (7), p.899-909
Main Authors: Ke, Lu, Zhou, Jing, Mao, Wenjian, Chen, Tao, Zhu, Yin, Pan, Xinting, Mei, Hong, Singh, Vikesh, Buxbaum, James, Doig, Gordon, He, Chengjian, Gu, Weili, Lu, Weihua, Tu, Shumin, Ni, Haibin, Zhang, Guoxiu, Zhao, Xiangyang, Sun, Junli, Chen, Weiwei, Song, Jingchun, Shao, Min, Tu, Jianfeng, Xia, Liang, He, Wenhua, Zhu, Qingyun, Li, Kang, Yao, Hongyi, Wu, Jingyi, Fu, Long, Jiang, Wendi, Zhang, He, Lin, Jiajia, Li, Baiqiang, Tong, Zhihui, Windsor, John, Liu, Yuxiu, Li, Weiqin
Format: Article
Language:English
Subjects:
Acute Disease
Age
Anesthesiology
Clinical outcomes
Clinical trials
Computed tomography
Critical Care Medicine
Double-Blind Method
Double-blind studies
Drug therapy
Emergency Medicine
Gangrene
Health aspects
Humans
Immunocompetence
Immunosuppression
Immunotherapy
Infections
Intensive
Intensive care
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Necrosis
Original
Pain Medicine
Pancreatitis
Pancreatitis, Acute Necrotizing - complications
Pancreatitis, Acute Necrotizing - diagnostic imaging
Patients
Pediatrics
Placebos
Pneumology/Respiratory System
Subgroups
Thymosin
Treatment Outcome
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Summary:Purpose Infected 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. Methods We 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. Results A 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%). Conclusion The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.
ISSN:0342-4642
1432-1238
DOI:10.1007/s00134-022-06745-7