The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anaesthesia (PRETREAT): clinical trial protocol and considerations.

Background: Intraoperative hypotension has been extensively studied for its association with adverse outcomes. However, small sample sizes and methodological issues limit the causal inference that can be drawn. Methods: In this multicentre, adaptive, randomised controlled trial, we will include 5000 adult inpatients scheduled for elective non-cardiac surgery under general or central neuraxial anaesthesia. Patients will be either randomly allocated to the intervention or care-as-usual group using computer-generated blocks of four, six, or eight, with an allocation ratio of 1:1. In the intervention arm patients will be divided into low-, intermediate-, and high-risk groups based on their likelihood to experience intraoperative hypotension, with resulting mean blood pressure targets of 70, 80, and 90 mm Hg, respectively. Anaesthesia teams will be provided with a clinical guideline on how to keep patients at their target blood pressure. During the first 6 months of the trial the intervention strategy will be evaluated and further revised in adaptation cycles of 3 weeks if necessary, to improve successful impact on the clinical process. The primary outcome is postoperative disability after 6 months measured with the World Health Organization Disability Assessment Score (WHODAS) 2.0 questionnaire. Ethics and dissemination: This study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht (20-749) and all protocol amendments will be communicated to the Medical Ethics Committee. The study protocol is in adherence with the Declaration of Helsinki and the guideline of Good Clinical Practice. Dissemination plans include publication in a peer-reviewed journal. Clinical trial registration: The Dutch Trial Register, NL9391. Registered on 22 March 2021.

Selecting and evaluating decision-making strategies in the intensive care unit: A systematic review.

PURPOSE: Many patients in the Intensive Care Unit (ICU) die after a decision to withhold or withdraw treatment. To ensure that for each patient the appropriate decision is taken, a careful decision-making process is required. This review identifies strategies that can be used to optimize the decision-making process for continuing versus limiting life sustaining treatment of ICU patients. METHODS: We conducted a systematic review of the literature by searching PUBMED and EMBASE. RESULTS: Thirty-two studies were included, with five categories of decision-making strategies (1) integrated communication, (2) consultative communication, (3) ethics consultation, (4) palliative care consultation and (5) decision aids. Many different outcome measures were used and none of them covered all aspects of decisions on continuing versus limiting life sustaining treatment. Integrated communication strategies had a positive effect on multiple outcome measures. Frequent, predefined family-meetings as well as triggered and integrated ethical or palliative consultation were able to reduce length of stay of patients who eventually died, without increasing overall mortality. CONCLUSIONS: The decision-making process in the ICU can be enhanced by frequent family-meetings with predefined topics. Ethical and palliative support is useful in specific situations. These interventions can reduce non-beneficial ICU treatment days.