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



Ke, Lu, Zhou, Jing, Mao, Wenjian, Chen, Tao ORCID: 0000-0002-5489-6450, Zhu, Yin, Pan, Xinting, Mei, Hong, Singh, Vikesh, Buxbaum, James, Doig, Gordon
et al (show 27 more authors) (2022) Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial. INTENSIVE CARE MEDICINE, 48 (7). pp. 899-909.

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Abstract

<h4>Purpose</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusion</h4>The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.

Item Type: Article
Uncontrolled Keywords: Acute pancreatitis, Immunosuppression, Thymosin, Pancreatic necrosis, Infection
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 27 Jun 2022 09:29
Last Modified: 17 Jun 2023 01:30
DOI: 10.1007/s00134-022-06745-7
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3157294