Evidence map›Paper›PMID 25169040›Full record

Trial reportTrials2014

SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients.

Christian Stoppe, Bernard McDonald, Steffen Rex, William Manzanares, Richard Whitlock, Stephen Fremes, Robert Fowler, Yoan Lamarche, Patrick Meybohm, Christoph Haberthür and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02002247 (SodiUm SeleniTe Adminstration IN Cardiac Surgery), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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.

NCT02002247 phase3unknown statusnot on this mapstarted 2015, after this paper: background citation

SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial). A Multicentre Randomized Controlled Trial of High Dose Sodium-selenite Administration in High Risk Cardiac Surgical Patients

TypeinterventionalSponsorDaren K. HeylandRan2015 to 2021Enrolled1,400ConditionsHeart DiseaseArmssodium selenite, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Biomarkers in critical care nutrition.Critical care (London, England) · 2020
    Review
  8. Review
  9. What's new in trace elements?Intensive care medicine · 2018
    Article
  10. Novel Therapies for Acute Kidney Injury.Kidney international reports · 2017
    Review
  11. Article
  12. Observational
  13. Article
  14. 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

15 authors at 12 institutions in 5 countries.

Christian StoppeDepartment of Anesthesiology, University Hospital of the RWTH Aachen, Pauwelsstraße 30, 52074 Aachen, Germany. christian.stoppe@gmail.com.
Bernard McDonald
Steffen Rex
William Manzanares
Richard Whitlock
Stephen Fremes
Robert Fowler
Yoan Lamarche
Patrick Meybohm
Christoph Haberthür
Rolf Rossaint
Andreas Goetzenich
Gunnar Elke
Andrew Day
Daren K Heyland
RWTH Aachen University · DEKingston General Hospital · CAHealth Sciences Centre · CAKlinik Hirslanden · CHKU Leuven · BEMcMaster University · CAMontreal Heart Institute · CASunnybrook Health Science Centre · CAUniversidad de la República · UYUniversity Hospital Frankfurt · DEUniversity Hospital Schleswig-Holstein · DEUniversity of Ottawa · CA

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundCardiac surgery has been shown to result in a significant decrease of the antioxidant selenium, which is associated with the development of multiorgan dysfunction and increased mortality. Thus, a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence of postoperative organ dysfunction. METHODS/

designWe plan a prospective, randomized double-blind, multicenter controlled trial, which will be conducted in North and South America and in Europe. In this trial we will include 1,400 high-risk patients, who are most likely to benefit from selenium supplementation. This includes patients scheduled for non-emergent combined and/or complex procedures, or with a predicted operative mortality of ≥ 5% according to the EuroSCORE II. Eligible patients will be randomly assigned to either the treatment group (bolus infusion of 2,000 μg sodium selenite immediately prior to surgery, followed by an additional dosage of 2,000 μg at ICU admission, and a further daily supplementation of 1,000 μg up to 10 days or ICU discharge) or to the control group (placebo administration at the same time points).The primary endpoint of this study is a composite of 'persistent organ dysfunction' (POD) and/or death within 30 days from surgery (POD + death). POD is defined as any need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or new intermittent hemodialysis) at any time within 30 days from surgery. DISCUSSION: The SUSTAIN-CSX™ study is a multicenter trial to investigate the effect of a perioperative high dosage sodium selenite supplementation in high-risk cardiac surgical patients.

trial registrationThis trial was registered at Clinicaltrials.gov (identifier: NCT02002247) on 28 November 2013.

Indexed as

Research DesignAnti-Inflammatory AgentsAntioxidantsCardiac Surgical ProceduresClinical ProtocolsDouble-Blind MethodDrug Administration ScheduleEuropeHumansMultiple Organ FailureNorth AmericaPerioperative CareProspective StudiesRisk AssessmentRisk FactorsSodium SeleniteAnti-Inflammatory AgentsAntioxidantsSodium Selenite

Identifiers

PMID25169040
PMCPMC4247649
OpenAlexW2145997941

What OpenQuestion holds

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LicenceCC BY
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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.