Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial.

BACKGROUND: Acute kidney injury (AKI) is a significant postoperative complication associated with increased mortality and hospital costs. Hemodynamic strategies, such as goal-directed therapy, might reduce AKI risk. Predicting and proactively managing intraoperative hypotension may be helpful. This trial aims to investigate if a preemptive hemodynamic strategy guided by the hypotension prediction index (HPI) can decrease the incidence of moderate-to-severe AKI within 30 days following major elective abdominal surgery. METHODS: This is an open-label, controlled, multicenter, randomized clinical trial that involves daily patient follow-up until hospital discharge. Inclusion criteria are patients aged over 65 and/or categorized as ASA III or IV physical status, undergoing major elective abdominal surgery (general, urological, or gynecological procedures) via laparoscopic or open approach under general or combined anesthesia. INTERVENTION: In the intervention group, hemodynamic management will be based on the HPI and the advanced functional hemodynamic variables provided by the Hemosphere platform and the AcumenIQ® sensor (Edwards Lifesciences). The primary outcome is the incidence of moderate-to-severe AKI within 7 days post-surgery. Secondary outcomes include postoperative complications and 30-day mortality. DISCUSSION: This study explores the potential of HPI-guided hemodynamic management in reducing AKI after major elective abdominal surgery, with implications for postoperative outcomes and patient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05569265. Registered on October 6, 2022.

Restrictive versus liberal transfusion strategy for red blood cell transfusion in critically ill patients and in patients with acute coronary syndrome: a systematic review, meta-analysis and trial sequential analysis.

INTRODUCTION: The risks and benefits of transfusing critically ill patients continue to evoke controversy. Specifically, the critically ill patients with active ischemic cardiac disease continue to represent a "gray area" in the literature. EVIDENCE ACQUISITION: Meta-analysis of the effects of lower versus higher hemoglobin thresholds on mortality in critically ill patients was carried out using PRISMA methodology. A systematic research was performed in PubMed, Embase, and the Cochrane Library (last update, December 2014). INCLUSION CRITERIA: Anemic critically ill adult patients admitted to intensive care units and/or anemic patients with acute coronary syndrome in which a restrictive vs. liberal transfusion therapy was compared. PRIMARY ENDPOINT: mortality. Included studies were subjected to quantifiable analysis, predefined subgroup analysis, trial sequential analysis and predefined sensitivity analysis. EVIDENCE SYNTHESIS: Thirty RCT's were initially identified; 6 fulfilled the inclusion criteria, including 2156. There were no differences in mortality between the restrictive and liberal groups (RR: 0.86, 95% CI 0.70-1.05 P=0.14), neither in patients with chronic cardiovascular disease subgroup (RR: 1.13, 95% IC 0.88-1.46 P=0.34). However, there is a trend towards decreased mortality in the subgroup critically ill (RR: 0.86, 95% CI 0.73-1.01 P=0.06); while in the subgroup of patients with acute myocardial infarct seems like it might be a non-significant trend towards increased mortality (RR: 3.85, 95% CI 0.82-18.0 P=0.09). CONCLUSIONS: Restrictive strategy is at least as effective to liberal strategy in critically ill patients. Nevertheless, there is insufficient evidence to recommend a restrictive strategy for patients with acute coronary syndrome.