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- Lingliang Zhou, Gordon S Doig, Cheng Lv, Lu Ke, Weiqin Li, and Chinese Critical Care Nutrition Trials Group (CCCNTG).
- Medical School of Southeast University, Nanjing, China.
- Crit Care Resusc. 2024 Dec 1; 26 (4): 326331326-331.
ObjectiveThere is uncertainty about whether early infusion of intravenous amino acids confers clinical benefits in critically ill patients. In this study, we aimed to test the hypothesis that intravenous amino acids could improve 90-day mortality in critically ill patients with normal kidney function.DesignThis is a multicentre, open-label, randomised, parallel-controlled trial.Setting20 ICUs across China.Participants1928 eligible critically ill patients with normal kidney function.InterventionsIn addition to standard care, patients assigned to the intervention group will receive a continuous infusion of amino acids at a rate to achieve a total daily protein intake of approximately 2.0 g/kg/day.Main Outcome MeasuresThe primary endpoint is all-cause mortality at day 90 after randomisation. Secondary endpoints and process measures will also be reported. The primary conclusions will be based on a modified intention-to-treat analysis for efficacy.Ethics And DisseminationThis study was approved by the ethics committee of the Jinling Hospital, Nanjing University (2020-NZKY-014-02 for the original version and 2020-NZKY-014-06 for the revised version) and all the participating sites. Results will be disseminated through journal publications and conference presentations.RegistrationThis study protocol was registered with the Chinese Clinical Trial Registry, and the identifier is ChiCTR2100053359 (https://www.chictr.org.cn/hvshowprojectEN.html?id=257327&v=1.7).© 2024 The Authors.
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