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

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.