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JAMA · 2026

Intraoperative Dobutamine Plus Norepinephrine to Prevent Postoperative Acute Kidney Injury in Septic Shock: A Randomized Clinical Trial.

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Chinese Perioperative Septic Shock Investigators for the Chinese Peri-Operative Organ Protection Group, Chu Lihua, Xie Guohao, Shi Rui, Ye Hui, Wu Shuijing, Hua Yejing, Wang Bingduo, Tang Mengyan, Xu Zhixin, Wang Qiaohong, Cui Ping, Ye Jianrong, Hong Yi, Wang Jialing, Xu Guiping, Li Qingqing, Wang Chuanguang, Zheng Fang, Xia Zhongyuan, Song Wenqin, Wang Mingcang, Chen Lingyang, Lu Xianfu, Liu Xuesheng, Zheng Qiang, Tang Jing, Yan Zhenyi, Lang Bao, Yan Quanzhang, Liu Wenjie, Luo Jie, Wang Kun, Lu Yaping, Huang Changshun, Wang Jun, Zhang Hongfei, Li Fengxian, Lu Kaizhi, Yi Bin, Gu Jianteng, Wu Jimin, Duan Gongchen, Li Chao, Luo Foquan, Wang Hongfa, Zhang Jiaqiang, Han Yaqian, Tan Dianxiang, Wen Jian, Wan Haifang, Hu Guangjun, Yu Tian, Wang Haiying, Mei Wei, Liu Zhiheng, Yu Songyang, Guan Yingchao, Wang Xin, Ma Bin, Yang Yihui, Wang Hui, Wu Xiaodan, Chen Yu, Lai Zhongmeng, Han Xuemin, Ji Fuhai, Yang Shiyue, Wu Yanqin, Li Ruru, Xu Pingbo, Yang Jianjun, Nian Chunmiao, Yu Yonghao, Wang Hongwei, An Xiaoxia, Cheng Baoli, Li Hui, Song Shengwen, Ma Daqing, Islam Nazrul, Fang Xiangming

Аннотация

IMPORTANCE: International guidelines recommend dobutamine for management of septic shock and cardiac dysfunction with persistent hypoperfusion in adults based on very low-certainty evidence. Randomized trials are lacking on the effect of intraoperative dobutamine combined with norepinephrine vs norepinephrine on postoperative outcomes in patients with septic shock undergoing surgical source control.

OBJECTIVE: To determine whether intraoperative dobutamine combined with norepinephrine reduces acute kidney injury (AKI) within 7 postoperative days in patients with septic shock undergoing surgical source control.

DESIGN, SETTING, AND PARTICIPANTS: This randomized, open-label clinical trial in 39 tertiary hospitals in China enrolled adults with septic shock who were undergoing surgical source control between June 2024 and August 2025. Follow-up ended on November 15, 2025.

INTERVENTION: Intraoperative, intravenous infusion of dobutamine (up to 5 µg/kg/min) combined with norepinephrine vs norepinephrine alone.

MAIN OUTCOMES AND MEASURES: The primary outcome was new-onset AKI or worsening of preoperative AKI within 7 days after surgery, defined using Kidney Disease: Improving Global Outcomes (KDIGO) criteria. The 11 secondary outcomes included Sequential Organ Failure Assessment (SOFA) score on postoperative day 1 and urine output 1 hour post intervention.

RESULTS: Among 584 patients (median [IQR] age, 67.5 [55.0-76.0] years; 192 [32.9%] females), new-onset or worsening AKI within 7 postoperative days occurred in 22.8% (66/290) randomized to receive dobutamine plus norepinephrine vs 34.7% (102/294) randomized to receive norepinephrine alone (adjusted risk ratio [ARR], 0.64 [95% CI, 0.49-0.83]). No significant differences were observed in 9 of the 11 secondary outcomes. SOFA scores on postoperative day 1 (adjusted difference, -0.53 [95% CI, -0.98 to -0.07]) were lower and urine output 1 hour post intervention (adjusted difference, 0.55 [95% CI, 0.03 to 1.07] mL/kg/h) was higher in the dobutamine plus norepinephrine group. Stage 2 and 3 AKI were lower in the dobutamine plus norepinephrine group compared with the norepinephrine alone group (stage 2: 4.8% vs 9.9%; ARR, 0.48 [95% CI, 0.26-0.88]; stage 3: 7.9% vs 13.6%; ARR, 0.56 [95% CI, 0.35-0.91]). Tachycardia (heart rate >100/min) occurred more frequently in patients receiving dobutamine and norepinephrine than norepinephrine alone.

CONCLUSIONS AND RELEVANCE: Among adult patients with septic shock undergoing surgical source control, intraoperative dobutamine combined with norepinephrine reduced the incidence of new-onset or worsening AKI within 7 postoperative days compared with norepinephrine.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06462313.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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