The effect of proactive versus reactive treatment of intraoperative hypotension on postoperative disability and outcome in surgical patients (PRETREAT): a randomized controlled trial

Methods

This was a two-center, adaptive, randomized controlled trial conducted in the Netherlands. Adult patients undergoing elective non-cardiac surgery were included. Patients were randomized to a stratified proactive blood pressure management strategy targeting a mean arterial pressure (MAP) ≥70, 80, or 90 mmHg based on hypotension risk, or to usual care.

The primary outcome was postoperative disability at six months, measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0. Secondary outcomes included quality of life, postoperative complications and mortality. Prespecified stopping rules for both efficacy and futility were incorporated in the study design.

Results: Will be published in the future. Conclusions: Will be published in the future. Registration: Dutch Trial Register (OMON register): NL9391 / NL-OMON55117 The data are sensitive since they involve information of patients.

There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC Utrecht.