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Multicenter Study
. 2025 May;51(5):883-892.
doi: 10.1007/s00134-025-07910-4. Epub 2025 May 13.

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

Akira Endo  1   2   3 , Kazuma Yamakawa  4 , Takashi Tagami  5 , Yutaka Umemura  6 , Takeshi Wada  7 , Ryo Yamamoto  8 , Hiroki Nagasawa  9 , Wataru Takayama  10 , Masayuki Yagi  11 , Kyosuke Takahashi  12 , Mitsuaki Kojima  10   13 , Chihiro Narita  14 , Satoshi Kazuma  15 , Jiro Takahashi  16 , Atsushi Shiraishi  17 , Masaki Todani  18 , Masaki Nakane  19 , Toshihiko Nagata  20 , Shohei Tanaka  21 , Yuta Yokokawa  22 , Kunihiko Takahashi  23 , Haruka Ishikita  24   10 , Ryo Hisamune  4 , Junichi Sasaki  8 , Ken-Ichi Muramatsu  9 , Hiroyuki Sonobe  11 , Kazunobu Minami  25 , Hiromasa Hoshi  24   10 , Yasuhiro Otomo  10   26 ; OPTPRESS trial investigators
Collaborators, Affiliations
Multicenter Study

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

Akira Endo et al. Intensive Care Med. 2025 May.

Abstract

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.

Keywords: Clinical trial; Critical care; Emergency medicine; Geriatrics; Septic shock.

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Conflict of interest statement

Declarations. Conflicts of interest: The authors declare no conflicts of interest that could influence or bias the implementation and results of this study.

Figures

Fig. 1
Fig. 1
Patient flow diagram. Patients aged ≥ 65 years who were clinically diagnosed with septic shock based on the Sepsis-3 criteria were assessed for eligibility. A total of 518 patients were randomly assigned to the high-target or control group in a 1:1 ratio. One patient from each group was excluded from the primary analysis because of inappropriate registration owing to technical errors. EDC electronic data capture, MAP mean arterial pressure
Fig. 2
Fig. 2
Blood pressure management according to mean arterial pressure target. The box and whisker plots show transition of median MAPs and interquartile ranges according to the target MAP. The red shaded region shows the target range of the high-MAP group, while blue shaded region shows the target range of the control group. Outliers are not shown. The target MAP was achieved 8 h after randomisation in majority of patients in the high-target group and 4 h after randomisation in the control group. Number of patients receiving vasopressors is also shown. The median vasopressor administration period in the high-target group and the control group was 65 h and 42 h, respectively. MAP mean arterial pressure
Fig. 3
Fig. 3
Kaplan–Meier curves for cumulative survival
See this image and copyright information in PMC

References

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