Adjunctive sepsis therapy with aminophylline (STAP): a randomized controlled trial. Issue 23 (5th December 2022)

• Record Type: Journal Article
• Authors: Zhang, Ruifang; Liu, Huan; Dai, Dongmei; Ding, Xianfei; Wang, Dong; Wang, Yan; Shi, Xuexiu; Zhang, Shuguang; Duan, Xiaoguang; Wang, Haixu; Luo, Yonggang; Liu, Shaohua; Han, Bing; Zhang, Xiaojuan; Fang, Yu; Yang, Jing; Xu, Wangbin; Sun, Tongwen
• Editors: Yin, Yanjie
• Is Part Of: Chinese medical journal. Volume 135:Issue 23(2022)
• Page Start: 2843
• Page End: 2850
• Publication Date: 2022-12-05
• Subjects: Aminophylline -- Mortality -- Randomized controlled trial -- Sepsis; Medicine -- Periodicals; Medicine, Oriental -- Periodicals; Medicine; Medicine, Oriental; Medicine; Medicine, East Asian Traditional; Periodicals; Electronic journals; 610.5
• DOI: 10.1097/CM9.0000000000002282
• Languages: English
• ISSNs: 0366-6999

Abstract

Abstract: Background: Sepsis is a serious disease caused by infection. Aminophylline has anti-asthma and anti-inflammatory effects. We aimed to explore the safety and effect of aminophylline in sepsis. Methods: We conducted a clinical randomized controlled trial involving 100 patients diagnosed with sepsis within 48 h after intensive care unit (ICU) admission in two sites. All patients were randomized in a 1:1 ratio to receive standard therapy with or without aminophylline. The primary clinical outcome was all-cause mortality at 28 days. Results: From September 27, 2018 to February 12, 2020, we screened 277 septic patients and eventually enrolled 100 patients, with 50 assigned to the aminophylline group and 50 to the usual-care group. At 28 days, 7 of 50 patients (14.0%) in the aminophylline group had died, compared with 16 of 50 (32.0%) in the usual-care group ( P = 0.032). Cox regression showed that the aminophylline group had a lower hazard of death (hazard ratio = 0.312, 95% confidence interval: 0.129–0.753). Compared with the usual-care group, patients in the aminophylline group had a longer survival time ( P = 0.039 by the log-rank test). The effects of aminophylline on vasopressor dose, oxygenation index, and sequential organ failure assessment score were time-dependent with treatment. There were no significant differences in total hospitalization days, ICU hospitalization days, and rates of serious adverse events (all P > 0.05). No adverse events were observed in the trial. Conclusions: Aminophylline as an adjunct therapy could significantly reduce the risk of death and prolong the survival time of patients with sepsis. Trial registration: ChiCTR.org.cn, ChiCTR1800019173.