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Published in: Trials 1/2020

01-12-2020 | Care | Study protocol

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

Authors: Stefan J. Schaller, Kristina Fuest, Bernhard Ulm, Sebastian Schmid, Catherina Bubb, Rüdiger von Eisenhart-Rothe, Helmut Friess, Chlodwig Kirchhoff, Thomas Stadlbauer, Peter Luppa, Manfred Blobner, Bettina Jungwirth

Published in: Trials | Issue 1/2020

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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.
Appendix
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Literature
1.
Nepogodiev D, Martin J, Biccard B, Makupe A, Bhangu A, National Institute for Health Research Global Health Research Unit on Global S. Global burden of postoperative death. Lancet. 2019;393(10170):401..PubMedCrossRef
2.
Wiedermann CJ, Wiedermann W, Joannidis M. Hypoalbuminemia and acute kidney injury: a meta-analysis of observational clinical studies. Intensive Care Med. 2010;36(10):1657–65.PubMedCrossRefPubMedCentral
3.
Ataseven B, du Bois A, Reinthaller A, Traut A, Heitz F, Aust S, Prader S, Polterauer S, Harter P, Grimm C. Pre-operative serum albumin is associated with post-operative complication rate and overall survival in patients with epithelial ovarian cancer undergoing cytoreductive surgery. Gynecol Oncol. 2015;138(3):560–5.PubMedCrossRef
4.
Ganai S, Lee KF, Merrill A, Lee MH, Bellantonio S, Brennan M, Lindenauer P. Adverse outcomes of geriatric patients undergoing abdominal surgery who are at high risk for delirium. Arch Surg. 2007;142(11):1072–8.PubMedCrossRef
5.
Kim J, Shim SH, Oh IK, Yoon SH, Lee SJ, Kim SN, Kang SB. Preoperative hypoalbuminemia is a risk factor for 30-day morbidity after gynecological malignancy surgery. Obstet Gynecol Sci. 2015;58(5):359–67.PubMedPubMedCentralCrossRef
6.
7.
Skhirtladze K, Base EM, Lassnigg A, Kaider A, Linke S, Dworschak M, Hiesmayr MJ. Comparison of the effects of albumin 5%, hydroxyethyl starch 130/0.4 6%, and Ringer’s lactate on blood loss and coagulation after cardiac surgery. Br J Anaesth. 2014;112(2):255–64.PubMedCrossRef
8.
Zetterstrom H. Albumin treatment following major surgery. II. Effects on postoperative lung function and circulatory adaptation. Acta Anaesthesiol Scand. 1981;25(2):133–41.PubMedCrossRef
9.
Damiani E, Ince C, Orlando F, Pierpaoli E, Cirioni O, Giacometti A, Mocchegiani F, Pelaia P, Provinciali M, Donati A. Effects of the infusion of 4% or 20% human serum albumin on the skeletal muscle microcirculation in endotoxemic rats. PLoS One. 2016;11(3):e0151005.PubMedPubMedCentralCrossRef
10.
Rubin H, Carlson S, DeMeo M, Ganger D, Craig RM. Randomized, double-blind study of intravenous human albumin in hypoalbuminemic patients receiving total parenteral nutrition. Crit Care Med. 1997;25(2):249–52.PubMedCrossRef
11.
Caironi P, Tognoni G, Masson S, Fumagalli R, Pesenti A, Romero M, Fanizza C, Caspani L, Faenza S, Grasselli G, et al. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med. 2014;370(15):1412–21.PubMedCrossRef
12.
Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R, Investigators SS. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004;350(22):2247–56.PubMedCrossRef
13.
Mahkovic-Hergouth K, Kompan L. Is replacement of albumin in major abdominal surgery useful? J Clin Anesth. 2011;23(1):42–6.PubMedCrossRef
14.
Lee EH, Kim WJ, Kim JY, Chin JH, Choi DK, Sim JY, Choo SJ, Chung CH, Lee JW, Choi IC. Effect of exogenous albumin on the incidence of postoperative acute kidney injury in patients undergoing off-pump coronary artery bypass surgery with a preoperative albumin level of less than 4.0 g/dl. Anesthesiology. 2016;124(5):1001–11.PubMedCrossRef
15.
Yuan XY, Zhang CH, He YL, Yuan YX, Cai SR, Luo NX, Zhan WH, Cui J. Is albumin administration beneficial in early stage of postoperative hypoalbuminemia following gastrointestinal surgery?: a prospective randomized controlled trial. Am J Surg. 2008;196(5):751–5.PubMedCrossRef
16.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentralCrossRef
17.
Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007;60(9):919–28.PubMedCrossRef
18.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–13.PubMedPubMedCentralCrossRef
19.
Schmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016;20:50.PubMedPubMedCentralCrossRef
20.
Marx G. Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin: Intravasale Volumentherapie beim Erwachsenen - S3 Leitlinie. Anästh Intensivmed. 2014;55:671–8.
21.
Bundesärztekammer. Querschnitts-Leitlinien (BÄK) zur Therapie mit Blutkomponenten und Plasmaderivaten, 4 edn. Deutschland: Deutscher Ärzte-Verlag; 2014.
22.
Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999;88(1):83–90.PubMed
23.
Eberhart LH, Greiner S, Geldner G, Wulf H. Patient evaluation of postoperative recovery. An evaluation of the QoR scores in 577 patients. Anaesthesist. 2002;51(6):463–6.PubMedCrossRef
24.
Meintker L, Haimerl M, Ringwald J, Krause SW. Measurement of immature platelets with Abbott CD-Sapphire and Sysmex XE-5000 in haematology and oncology patients. Clin Chem Lab Med. 2013;51(11):2125–31.PubMedCrossRef
25.
Klingenberg B. A new and improved confidence interval for the Mantel-Haenszel risk difference. Stat Med. 2014;33(17):2968–83.PubMedCrossRef
26.
Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, et al. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017;117(10):1887–95.PubMedCrossRef
27.
Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, et al. Association of postoperative high-sensitivity troponin levels with myocardial injury and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2017;317(16):1642.PubMedCrossRef
28.
Anetsberger A, Blobner M, Krautheim V, Umgelter K, Schmid S, Jungwirth B. Self-reported, structured measures of recovery to detect postoperative morbidity. PLoS One. 2015;10(7):e0133871.PubMedPubMedCentralCrossRef
29.
Haynes GR, Navickis RJ, Wilkes MM. Albumin administration--what is the evidence of clinical benefit? A systematic review of randomized controlled trials. Eur J Anaesthesiol. 2003;20(10):771–93.PubMedCrossRef
30.
Myles PS, Grocott MP, Boney O, Moonesinghe SR, Group CO-S. Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth. 2016;116(5):586–9.PubMedCrossRef
Metadata
Title
Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial
Authors
Stefan J. Schaller
Kristina Fuest
Bernhard Ulm
Sebastian Schmid
Catherina Bubb
Rüdiger von Eisenhart-Rothe
Helmut Friess
Chlodwig Kirchhoff
Thomas Stadlbauer
Peter Luppa
Manfred Blobner
Bettina Jungwirth
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04626-2

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