Original Investigation 

Proactive vs Reactive Treatment of Hypotension During Surgery: The PRETREAT Randomized Clinical Trial

Matthijs Kant, Wilton A. van Klei, Markus W. Hollmann, et al

JAMA Published Online: October 12, 2025

doi: 10.1001/jama.2025.18007

Key Points

Question  Does intraoperative blood pressure management with a mean arterial pressure goal stratified by preoperatively determined risk of intraoperative hypotension improve postoperative functional disability at 6 months in patients undergoing elective noncardiac surgery?

Findings  In this randomized clinical trial including 3247 adults undergoing elective noncardiac surgery, targeting a mean atrial pressure of at least 70 mm Hg for patients at low risk, at least 80 mm Hg for those at intermediate risk, and at least 90 mm Hg for those at high risk of intraoperative hypotension did not improve postoperative disability at 6 months as measured by the World Health Organization Disability Assessment Schedule (range, 0 to 100; minimal clinically important difference, 5 percentage points) compared with usual intraoperative management that aimed to maintain a mean arterial pressure of at least 65 mm Hg at the discretion of the treating anesthesiologist (mean score, 17.7 vs 18.2, respectively).

Meaning  Proactive, risk-stratified blood pressure management did not improve postoperative disability at 6 months.

Abstract

Importance  Intraoperative hypotension is associated with adverse postoperative outcomes, but whether a proactive strategy to prevent intraoperative hypotension improves outcomes is uncertain.

Objective  To determine whether intraoperative blood pressure management stratified by risk of hypotension reduces postoperative functional disability compared with usual care in adults undergoing noncardiac surgery.

Design, Setting, and Participants  In this randomized clinical trial, adults undergoing elective noncardiac surgery at 2 tertiary hospitals in the Netherlands were enrolled from June 17, 2021, to February 7, 2024. The date of last follow-up was October 24, 2024.

Intervention  Patients were randomized 1:1 to proactive blood pressure management with mean arterial pressure targets based on risk of intraoperative hypotension (low risk, ≥70 mm Hg; intermediate risk, ≥80; high risk, ≥90) or usual management at their anesthesiologist’s discretion, generally aiming to avoid a mean arterial pressure of less than 65 mm Hg without higher predefined targets.

Main Outcomes and Measures  The primary outcome was functional disability at 6 months, assessed with the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; scale range, 0-100; higher scores indicate more disability). A minimally clinically important difference of 5 points was prespecified. There were 23 secondary outcomes, including quality of life, complications, and mortality within 6 months.

Results  The trial was stopped early for futility after 3247 of 5000 planned patients (median age, 59 years [IQR, 44-69]; 1738 female [53.5%]) were enrolled. A total of 677 patients (21%) were low risk; 1814 (56%), intermediate risk, and 756 (23%), high risk. Baseline median WHODAS scores were 12.5 [IQR, 4.2-29.2] in proactive group and 14.6 [IQR, 4.2-29.2] in standard group). At 6 months, mean (SD) WHODAS scores were 17.7 (20.1) in the proactive group and 18.2 (20.5) in the standard group (mean difference, –0.5; 95% credible interval, –1.9 to 0.9). There were no significant differences in any of the 23 secondary outcomes.

Conclusions and Relevance  Intraoperative blood pressure management with mean arterial pressure goals stratified by risk of hypotension did not improve functional disability at 6 months postoperatively compared with standard intraoperative blood pressure management.

Trial Registration  Overview of Medical Research in the Netherlands (CCMO): NL-OMON55117