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Title:

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

Document type:
Journal Article
Author(s):
Schaller, Stefan J; Fuest, Kristina; Ulm, Bernhard; Schmid, Sebastian; Bubb, Catherina; Eckstein, Hans-Henning; von Eisenhart-Rothe, Rüdiger; Friess, Helmut; Kirchhoff, Chlodwig; Luppa, Peter; Blobner, Manfred; Jungwirth, Bettina
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. BACKGROUND: 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 to 4 or undergoing high-risk surgery. Patients, whose serum albumin concentration dropped <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 in at least 1 of 9 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 60 g (40-80 g) was substituted to 299 (99.7%) patients in the intervention group and to 54 (18.0%) in the standard care group. At least 1 postoperative complication classified as Clavien-Dindo Classification ≥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.
Journal title abbreviation:
Ann Surg
Year:
2024
Journal volume:
279
Journal issue:
3
Pages contribution:
402-409
Fulltext / DOI:
doi:10.1097/SLA.0000000000006030
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/37477023
Print-ISSN:
0003-4932
TUM Institution:
Institut für Klinische Chemie und Pathobiochemie (Prof. Ruland); Klinik für Anästhesiologie (DHM); Klinik und Poliklinik für Chirurgie (Prof. Friess); Klinik und Poliklinik für Orthopädie und Sportorthopädie (Prof. von Eisenhart-Rothe); Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie (Prof. Eckstein)
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