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Randomized controlled trials reported in the literature are often affected by poor generalizability, and pragmatic trials have become an increasingly utilized workaround approach to overcome logistical limitations and explore routine interventions demonstrating equipoise in clinical practice. Intravenous albumin, for example, is commonly administered in the perioperative setting despite lacking supportive evidence. Given concerns for cost, safety, and efficacy, randomized trials are needed to explore the clinical equipoise of albumin therapy in this setting, and we therefore present an approach to identifying populations exposed to perioperative albumin to encourage clinical equipoise in patient selection and optimize study design for clinical trials.

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The impact of albumin use during major surgery is unknown, and a dearth of evidence governing its use in major non-cardiac surgery has long precluded its standardization in clinical guidelines.In this study we investigate institutional variation in albumin use among medical centers in the United States during major non-cardiac surgery and explore the association of intraoperative albumin administration with important post-operative outcomes.The study is an observational retrospective cohort analysis performed among 54 hospitals in the Multicenter Perioperative Outcomes Group (MPOG) and includes adult patients who underwent major non-cardiac surgery under general anesthesia between January 2014 and June 2020. The primary endpoint was the incidence of albumin administration. Secondary endpoints acute kidney injury (AKI), net-positive fluid balance, pulmonary complications, and 30-day mortality. Albumin-exposed and -unexposed cases were compared within a propensity score-matched cohort to evaluate associations of albumin use with outcomes.Among 614,215 major surgery cases, albumin was used in 15.3% (mostly isooncotic albumin) but with significant inter-institutional variability in use patterns. Cases involving intraoperative albumin administration were of a higher American Society of Anesthesiologists (ASA) physical status and received larger infused crystalloid volumes, had higher blood loss, and vasopressor use. Overall, albumin was most often administered at high-volume surgery centers with academic affiliation, and within a propensity score-matched cohort (n=153,218), the use of albumin was associated with AKI (aOR 1.24, 95% CI 1.20-1.28, P0.001), severe AKI (aOR 1.45, 95% CI 1.34-1.56, P0.001), net-positive fluid balance (aOR 1.18, 95% CI 1.16-1.20, P0.001), pulmonary complications (aOR 1.56, 95% CI 1.30-1.86, P0.001), and 30-day all-cause mortality (aOR 1.37, 95% CI 1.26-1.49, P0.001).Intravenous albumin is commonly administered among non-cardiac surgeries with significant inter-institutional variability in use in the United States. Albumin was associated with an increased risk of postoperative complications.