Intensive care medicine · 2025
Efficacy of targeting high mean arterial pressure for older patients with septic shock (OPTPRESS): a multicentre, pragmatic, open-label, randomised controlled trial.
СтатьяМногоцентровое исследованиеPragmatic Clinical TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Endo Akira, Yamakawa Kazuma, Tagami Takashi, Umemura Yutaka, Wada Takeshi, Yamamoto Ryo, Nagasawa Hiroki, Takayama Wataru, Yagi Masayuki, Takahashi Kyosuke, Kojima Mitsuaki, Narita Chihiro, Kazuma Satoshi, Takahashi Jiro, Shiraishi Atsushi, Todani Masaki, Nakane Masaki, Nagata Toshihiko, Tanaka Shohei, Yokokawa Yuta, Takahashi Kunihiko, Ishikita Haruka, Hisamune Ryo, Sasaki Junichi, Muramatsu Ken-Ichi, Sonobe Hiroyuki, Minami Kazunobu, Hoshi Hiromasa, Otomo Yasuhiro, OPTPRESS trial investigators
Аннотация
PURPOSE: We examined the effect of a high-target mean arterial pressure (MAP) on septic shock in a previously underrepresented region.
METHODS: A multicentre, pragmatic, open-label, randomised controlled trial was conducted in 29 hospitals in Japan, where the prevalence of chronic hypertension among older individuals is 66.9%. Patients who were diagnosed with septic shock, aged ≥ 65 years, and admitted to an intensive care unit were randomised 1:1 to the high (target MAP = 80-85 mmHg) or control (target MAP = 65-70 mmHg) groups from 1 July 2021 to 12 December 2023. The target MAP was maintained for 72 h or until vasopressors were no longer required. The primary outcome was the 90-day all-cause mortality. Secondary outcomes included organ support-free days and adverse events.
RESULTS: The trial was terminated early on the basis of the interim analysis results, suggesting the harm of the high-target strategy. Of the 518 patients, 258 were in the high-target group, and 260 were in the control group. By 90 days after randomisation, 101 patients (39.3%) in the high-target group and 74 (28.6%) in the control group had died from any cause (risk difference = 10.7; 95% confidence interval, 2.6-18.9). Renal replacement therapy-free days at 28 days were shorter in the high-target group. No clinical benefits for any outcome were observed in any subpopulation, including those with known chronic hypertension.
CONCLUSION: Among older patients with septic shock, high-target MAP significantly increased mortality compared with standard care.
TRIAL REGISTRATION: UMIN Clinical Trials Registry; UMIN000041775; 13 September 2020.
METHODS: A multicentre, pragmatic, open-label, randomised controlled trial was conducted in 29 hospitals in Japan, where the prevalence of chronic hypertension among older individuals is 66.9%. Patients who were diagnosed with septic shock, aged ≥ 65 years, and admitted to an intensive care unit were randomised 1:1 to the high (target MAP = 80-85 mmHg) or control (target MAP = 65-70 mmHg) groups from 1 July 2021 to 12 December 2023. The target MAP was maintained for 72 h or until vasopressors were no longer required. The primary outcome was the 90-day all-cause mortality. Secondary outcomes included organ support-free days and adverse events.
RESULTS: The trial was terminated early on the basis of the interim analysis results, suggesting the harm of the high-target strategy. Of the 518 patients, 258 were in the high-target group, and 260 were in the control group. By 90 days after randomisation, 101 patients (39.3%) in the high-target group and 74 (28.6%) in the control group had died from any cause (risk difference = 10.7; 95% confidence interval, 2.6-18.9). Renal replacement therapy-free days at 28 days were shorter in the high-target group. No clinical benefits for any outcome were observed in any subpopulation, including those with known chronic hypertension.
CONCLUSION: Among older patients with septic shock, high-target MAP significantly increased mortality compared with standard care.
TRIAL REGISTRATION: UMIN Clinical Trials Registry; UMIN000041775; 13 September 2020.