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Purpose <p>We examined the effect of a high-target mean arterial pressure (MAP) on septic shock in a previously underrepresented region.</p> Methods <p>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&#xa0;years, and admitted to an intensive care unit were randomised 1:1 to the high (target MAP = 80–85&#xa0;mmHg) or control (target MAP = 65–70&#xa0;mmHg) groups from 1 July 2021 to 12 December 2023. The target MAP was maintained for 72&#xa0;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.</p> Results <p>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&#xa0;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&#xa0;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.</p> Conclusion <p>Among older patients with septic shock, high-target MAP significantly increased mortality compared with standard care.</p> Trial registration <p>UMIN Clinical Trials Registry; UMIN000041775; 13 September 2020.</p>

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Efficacy of targeting high mean arterial pressure for older patients with septic shock (OPTPRESS): a multicentre, pragmatic, open-label, randomised controlled trial

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  • 发表日期：

    2025年5月13日

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  • Akira Endo,
  • Kazuma Yamakawa,
  • Takashi Tagami,
  • Yutaka Umemura,
  • Takeshi Wada,
  • Ryo Yamamoto,
  • Hiroki Nagasawa,
  • Wataru Takayama,
  • Masayuki Yagi,
  • Kyosuke Takahashi,
  • Mitsuaki Kojima,
  • Chihiro Narita,
  • Satoshi Kazuma,
  • Jiro Takahashi,
  • Atsushi Shiraishi,
  • Masaki Todani,
  • Masaki Nakane,
  • Toshihiko Nagata,
  • Shohei Tanaka,
  • Yuta Yokokawa,
  • Kunihiko Takahashi,
  • Haruka Ishikita,
  • Ryo Hisamune,
  • Junichi Sasaki,
  • Ken-ichi Muramatsu,
  • Hiroyuki Sonobe,
  • Kazunobu Minami,
  • Hiromasa Hoshi,
  • Yasuhiro Otomo,
  • Tomohiko Akutsu,
  • Daiki Kaito,
  • Hiromichi Ohsaka,
  • Yohei Iwasaki,
  • Fumino Taketazu,
  • Tomoko Iguchi,
  • Ryu Azumaguchi,
  • Noritaka Ushio,
  • Takahiro Okane,
  • Toshiyuki Karumai,
  • Ayaka Matsuoka,
  • Chikashi Takeda,
  • Toshiki Sera,
  • Hiroko Okura,
  • Yoichi Katayama,
  • Keiichiro Shimoyama,
  • Tadanaga Shimada,
  • Ryuzo Abe,
  • Tsuyoshi Nakashima,
  • Tatsuhiko Anzai,
  • Keisuke Suzuki,
  • Takahiro Yamanaka,
  • Youichi Yanagawa,
  • Yuichi Araki

摘要

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.