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

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.

Informations de copyright

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Déclaration de conflit d'intérêts

Conflicts of interest: MB received research support from MSD (Haar, Germany) not related to this manuscript, received honoraria for giving lectures from GE Healthcare (Helsinki, Finland) and Grünenthal (Aachen, Germany). MB is a consultant to HW Pharmaconsulting (Moosach, Germany), Cosinuss° (Munich, Germany), MIPM (Mammendorf, Germany), SENZIME (Uppsala, Sweden) and Aspen Germany (Munich, Germany). SJS received grants and non-financial support from Reactive Robotics GmbH (Munich, Germany), ASP GmbH (Attendorn, Germany), STIMIT AG (Biel, Switzerland), ESICM (Geneva, Switzerland), grants, personal fees and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany), grants from the Innovationsfond of The Federal Joint Committee (G-BA), personal fees from Springer Verlag GmbH (Vienna, Austria) for educational purposes and Advanz Pharma GmbH (Bielefeld, Germany), non-financial support from national and international societies (and their congress organizers) in the field of anesthesiology and intensive care medicine, outside the submitted work. Dr. Schaller holds stocks in small amounts from Alphabeth Inc., Bayer AG and Siemens AG; these holdings have not affected any decisions regarding his research or this study. The other authors declare that they have no competing interests.