Goal-directed Perioperative Albumin Substitution Versus Standard of Care to Reduce Postoperative Complications - A Randomized Clinical Trial (SuperAdd Trial)

Abstract

Objective: To investigate whether goal-directed albumin substitution during surgery and postanesthesia care to maintain a serum albumin concentration >30 g/L can reduce postoperative complications. Summary Background Data: Hypoalbuminemia is associated with numerous postoperative complications. Since albumin has important physiological functions, substitution of patients with hypoalbuminemia is worth considering. Methods: We conducted a single center, randomized, controlled, outcome-assessor blinded clinical trial in adult patients, American Society of Anesthesiologists physical status classification 3-4 or undergoing high-risk surgery. Patients, whose serum albumin concentration dropped below 30 g/L were randomly assigned to goal-directed albumin substitution maintaining serum concentration >30 g/L or to standard care until discharge from the postanesthesia intermediate care unit. Standard of care allowed albumin substitution in hemodynamic instable patients with serum concentration <20 g/L, only. Primary outcome was the incidence of postoperative complications ≥2 according to the Clavien-Dindo Classification (CDC) in at least one of nine domains (pulmonary, infectious, cardiovascular, neurological, renal, gastrointestinal, wound, pain and hematological) until postoperative day 15. Results: Of 2509 included patients 600 (23.9%) developed serum albumin concentrations <30 g/L. Human albumin 60g (40–80g) was substituted to 299 (99.7%) patients in the intervention group and to 54 (18.0%) in the standard care group. At least one postoperative complication classified as CDC≥2 occurred in 254 of 300 patients (84.7%) in the intervention group and in 262 of 300 (87.3%) in the standard treatment group (risk difference -2.7%, 95%CI, -8.3% to 2.9%). Conclusion: Maintaining serum albumin concentration of >30 g/L perioperatively cannot generally be recommended in high-risk noncardiac surgery patients.