Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial

Abstract

Background: Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration > 30 g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care.

Methods/design: SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patient blinded controlled trial. The primary outcome is the frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ≥ 2 according to the Clavien-Dindo Score. Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery, are recruited after written informed consent was obtained. The albumin concentration is assessed before the induction of anesthesia and every 3 h until admission to the postanesthesia care unit. If albumin concentrations drop below 30 g/l, patients are randomly allocated to the control or the treatment group. The study intervention is a goal-directed human albumin substitution aimed at a concentration > 30 g/l during surgery and postanesthesia care unit stay. The patients in the control group are treated according to standard clinical care. Postoperative visits are to be performed on days 1, 3, 5, 8, and 15, as well as by telephone 6 months after surgery.

Discussion: SuperAdd is the first clinical trial in a surgical population investigating the effect of a goal-directed albumin substitution aiming at a serum level > 30 g/l. The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results.

Trial registration: EudraCT 2016-001313-24. Registered on 5 September 2016. Clinical Trials NCT03167645. Registered on 18 October 2016 and has the Universal Trial Number (UTN) U1111-1181-2625.

Keywords: Hypalbuminemia; Perioperative care; Postoperative care; Postoperative complications; Serum albumin.

Conflict of interest statement

SJS reports grants from MSD (Haar, Germany); non-financial support from Fresenius, Germany, from the Technical University of Munich, Germany, and from national (e.g., DGAI) and international (e.g., ESICM) medical societies or their congress organizers in the field of anesthesiology and intensive care; and personal fees and non-financial support from Bavarian Medical Association, all outside the submitted work; he holds stocks from Alphabet Inc., Rhoen-Klinikum, Bayer AG, and Siemens AG; these holdings have not affected any decisions regarding his research or this study. TS has received research funding grants from Bayer Pharm (Berlin, Germany) and is a lecturer for Bayer Pharm (Berlin, Germany), Bristol-Myers Squibb (Munich, Germany), Pfizer (Berlin, Germany), and Daiichi Sankyo (Munich, Germany). MB received research support from MSD (Haar, Germany) not related to this manuscript and received honoraria for giving lectures from GE Healthcare (Helsinki, Finland) and Grünenthal (Aachen, Germany). BJ received honoraria for giving lectures from Pulsion Medical Systems SE (Feldkirchen, Germany). The other authors declare that they have no competing interests.

Figures

Fig. 1

Schedule of enrolment, interventions, and assessments according to the SPIRIT guidelines [16]. PACU, postanesthesia care unit. The Postoperative Morbidity Survey (POMS) screens nine domains (pulmonary, infectious, cardiovascular, neurological, renal, gastrointestinal, wound, pain, and hematological morbidities) [17]. The severity of the complication is graded according to the Clavien-Dindo Score (Table 1) [18]