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

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.