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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.

SUBMITTER: Schaller SJ

PROVIDER: S-EPMC7433099 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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

Schaller Stefan J SJ Fuest Kristina K Ulm Bernhard B Schmid Sebastian S Bubb Catherina C von Eisenhart-Rothe Rüdiger R Friess Helmut H Kirchhoff Chlodwig C Stadlbauer Thomas T Luppa Peter P Blobner Manfred M Jungwirth Bettina B

Trials 20200818 1

<h4>Background</h4>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.<h4>Methods/design</h4>SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patie ...[more]

PMID: 32811539

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Project description:BackgroundCompliance with perioperative anticoagulation guidelines is essential to minimize bleeding and thromboembolic risks in patients undergoing surgery. Compared to vitamin-K antagonists (VKAs), perioperative management of direct oral anticoagulants (DOACs) contains fewer steps. Therefore, we hypothesized that noncompliance with guidelines in VKA users is higher than in DOAC users. The primary aim of our study was to investigate the difference in noncompliance to perioperative anticoagulant management guidelines between elderly patients using VKAs versus those using DOACs. The secondary aim was to determine the difference in occurrence of conflicting information communicated to the patients and the difference in incidence of coagulation-related adverse events.MethodsThis retrospective non-controlled observational cohort study examined elderly patients undergoing elective orthopedic surgery in a teaching hospital in the Netherlands. All patients undergoing elective orthopedic surgery between 1 May 2016 and 1 January 2020, aged 70 years and over, using VKAs or DOACs were selected. Nonelective surgeries were excluded. The primary outcome was the noncompliance to perioperative anticoagulant management guidelines. Secondary outcomes were missing or conflicting information on anticoagulation management communicated to the patient and coagulation-related adverse events. For continuous data, the unpaired T-test was used and for categorical data, the chi-square test.ResultsIn patients using VKAs, noncompliance to one of the steps of perioperative anticoagulation management was 81%, compared to 55% in patients using DOACs (p < 0.001). In most cases, VKAs or DOACs were interrupted for longer than recommended. In 13% of patients using a VKA with perioperative bridging, bridging was not conducted as recommended in the guidelines. In 13% of patients using a DOAC, a low-molecular-weight heparin (LMWH) was prescribed while a DOAC had already been restarted postoperatively. VKA users received conflicting information about perioperative anticoagulation management more often than DOAC users (33% versus 20%; p < 0.001). No difference was seen in postoperative coagulation-related complications.ConclusionGuidelines compliance in DOAC users is higher than in VKA users. Clinical decision support to help in selecting the right interruption interval in DOAC users, simplified standardized perioperative management, good coordination of instructions given to patients, and familiarity with updated guidelines are important in reducing noncompliance.

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Dataset Information

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

Publications

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

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