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Background <p>Minimizing relative hypotension, or mean arterial pressure (MAP) deficit, by targeting patients’ own pre-illness MAP (individualized MAP) during vasopressor therapy is a potential strategy to improve outcomes among ICU patients with shock. We conducted a prospective, open label, parallel-group, pilot RCT to assess feasibility and safety of this intervention compared to standard care.</p> Methods <p>Thirty-seven eligible patients, aged 40&#xa0;years or older and receiving vasopressor support for shock, were randomly allocated to individualized MAP target (<i>N</i> = 17) or standard MAP target (<i>N</i> = 20) at two multidisciplinary ICUs in Australia and Ireland. Pre-specified endpoints were time-weighted average MAP-deficit (i.e., percentage difference between patients’ pre-illness MAP and achieved-MAP), percentage time spent with &gt; 20% MAP-deficit, major adverse kidney events (MAKE-14), 14-day and 90-day all-cause mortality, and cardiovascular adverse events within 28&#xa0;days of randomization. All comparisons of efficacy outcomes were exploratory.</p> Results <p>The median MAP-deficit and percentage time with &gt; 20% MAP-deficit with individualized MAP <i>vs.</i> standard MAP were 7% [interquartile range: 2–16] <i>vs.</i> 18% [9–23] (<i>p</i> = 0.048), and 8% [0–43] <i>vs.</i> 53% [14–75] (<i>p</i> = 0.03), respectively. MAKE-14 (2/17 (12%) <i>vs.</i> 4/20 (20%), <i>p</i> = 0.67), 14-day mortality (1/17 (6%) <i>vs.</i> 3/20 (15%), <i>p</i> = 0.61), 90-day mortality (2/17 (12%) <i>vs.</i> 4/20 (20%), <i>p</i> = 0.67) and cardiovascular adverse events were similar for both groups.</p> Conclusions <p>This pilot RCT demonstrated that an individualized MAP target strategy was feasible to implement. No adverse safety signals were evident. These data and study procedures helped inform the design of a definitive RCT on the question of individualized MAP targets among critically ill patients with shock.</p> <p><i>Study registration</i>: ACTRN12618000571279.</p>

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A pilot multicenter randomized controlled trial on individualized blood pressure targets versus standard care among critically ill patients with shock

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  • 发表日期：

    2025年5月27日

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  • Rakshit Panwar,
  • Bairbre McNicholas,
  • Ciprian Nita,
  • Alison Gibberd,
  • Amber-Louise Poulter,
  • Marcia Tauares,
  • Lauren Ferguson

摘要

Background

Minimizing relative hypotension, or mean arterial pressure (MAP) deficit, by targeting patients’ own pre-illness MAP (individualized MAP) during vasopressor therapy is a potential strategy to improve outcomes among ICU patients with shock. We conducted a prospective, open label, parallel-group, pilot RCT to assess feasibility and safety of this intervention compared to standard care.

Methods

Thirty-seven eligible patients, aged 40 years or older and receiving vasopressor support for shock, were randomly allocated to individualized MAP target (N = 17) or standard MAP target (N = 20) at two multidisciplinary ICUs in Australia and Ireland. Pre-specified endpoints were time-weighted average MAP-deficit (i.e., percentage difference between patients’ pre-illness MAP and achieved-MAP), percentage time spent with > 20% MAP-deficit, major adverse kidney events (MAKE-14), 14-day and 90-day all-cause mortality, and cardiovascular adverse events within 28 days of randomization. All comparisons of efficacy outcomes were exploratory.

Results

The median MAP-deficit and percentage time with > 20% MAP-deficit with individualized MAP vs. standard MAP were 7% [interquartile range: 2–16] vs. 18% [9–23] (p = 0.048), and 8% [0–43] vs. 53% [14–75] (p = 0.03), respectively. MAKE-14 (2/17 (12%) vs. 4/20 (20%), p = 0.67), 14-day mortality (1/17 (6%) vs. 3/20 (15%), p = 0.61), 90-day mortality (2/17 (12%) vs. 4/20 (20%), p = 0.67) and cardiovascular adverse events were similar for both groups.

Conclusions

This pilot RCT demonstrated that an individualized MAP target strategy was feasible to implement. No adverse safety signals were evident. These data and study procedures helped inform the design of a definitive RCT on the question of individualized MAP targets among critically ill patients with shock.

Study registration: ACTRN12618000571279.