Evidence map›Paper›PMID 32811539›Full record

ArticleTrials2020

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

Stefan J Schaller, Kristina Fuest, Bernhard Ulm, Sebastian Schmid, Catherina Bubb, Rüdiger von Eisenhart-Rothe, Helmut Friess, Chlodwig Kirchhoff, Thomas Stadlbauer, Peter Luppa and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03167645 (Does Perioperative Substitution of Albumin Deficiency Reduce Postoperative Complications?), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03167645 phase4completednot on this map

Does Perioperative Substitution of Albumin Deficiency Reduce Postoperative Complications?

TypeinterventionalSponsorTechnical University of MunichRan2017 to 2021Enrolled600ConditionsHypoalbuminemiaArmsHuman albumin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Hypoalbuminemia as Surrogate and Culprit of Infections.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Stefan J SchallerDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Kristina FuestDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Bernhard UlmDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Sebastian SchmidDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Catherina BubbDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Rüdiger von Eisenhart-RotheDepartment of Orthopedics, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Helmut FriessDepartment of Surgery, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Chlodwig KirchhoffDepartment of Traumatology, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Thomas StadlbauerDepartment of Vascular Surgery, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Peter LuppaInstitute of Clinical Chemistry and Pathobiochemistry, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Manfred BlobnerDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.ORCID http://orcid.org/0000-0002-0370-5247
Bettina JungwirthDepartment of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany. bettina.jungwirth@uniklinik-ulm.de.
TUM Klinikum · DEUniversität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHypalbuminemia 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/

designSuperAdd 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 registrationEudraCT 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.

Indexed as

AbdomenOrthopedic ProceduresVascular Surgical ProceduresAdultAlbuminsHumansHypoalbuminemiaPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicSerum Albumin, HumanWounds and InjuriesAlbuminsSerum Albumin, HumanHypalbuminemiaPerioperative carePostoperative carePostoperative complicationsSerum albumin

Identifiers

PMID32811539
PMCPMC7433099
OpenAlexW3057503699

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.