Evidence map›Paper›PMID 29084247›Full record

Trial reportPloS one2017

The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial.

Dirk Schädler, Christine Pausch, Daniel Heise, Andreas Meier-Hellmann, Jörg Brederlau, Norbert Weiler, Gernot Marx, Christian Putensen, Claudia Spies, Achim Jörres and 4 more

5 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 197 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 6 pooled it
16.0field-weighted citation impact, top 1% 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.

NCT04306419 unknown statusnot on this mapstarted 2020, after this paper: background citation

Observational Trial on Cytokine Adsorption in Sepsis

TypeobservationalSponsorRWTH Aachen UniversityRan2020 to 2024Enrolled100ConditionsSepsis, Septic Shock, Multiple Organ Failure
NCT04742764 phase3suspendednot on this mapstarted 2024, after this paper: background citation

Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial

TypeinterventionalSponsorUniversity of PecsRan2024 to 2027Enrolled135ConditionsSeptic ShockArmsStandard medical therapy, Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours, Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours
NCT05042622 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Innovative Solutions to Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure

TypeinterventionalSponsorNational Research Center for Cardiac Surgery, KazakhstanRan2021 to 2023Enrolled90ConditionsAcute Respiratory Distress Syndrome, Septic Shock, SepsisArmsCytokine adsorber filter, Extracorporeal hemoperfusion cartridge
NCT05090930 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life

TypeinterventionalSponsorNational Research Center for Cardiac Surgery, KazakhstanRan2021 to 2023Enrolled100ConditionsCardiogenic Shock, Ventricular Arrythmia, Cardiac Arrest With Successful Resuscitation, SepsisArmsHA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber
NCT07033910 completednot on this mapstarted 2023, after this paper: background citation

The Effect of Extracorporeal Sepsis Adsorption Column Use on Plasma Syndecan-1 Level and Mortality in Sepsis Patients

TypeobservationalSponsorOral MENTEŞRan2023 to 2024Enrolled91ConditionsSepsis, Syndecan 1, Extracorporeal Sepsis Adsorption ColumnArmssepsis adsorption column
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 6 syntheses or guidelines pooled it, 348 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
    Guideline
  6. Pooled it
  7. Trial
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  12. The unrestricted global effort to complete the COOL trial.World journal of emergency surgery : WJES · 2023
    Trial
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  14. Trial
  15. Extracorporeal HemadsorptionCardiovascular therapeutics · 2020
    Trial
  16. Trial
  17. Review
  18. Review
  19. Observational
  20. Review

137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 2 countries.

Dirk SchädlerDepartment of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.ORCID http://orcid.org/0000-0002-5745-4797
Christine PauschInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.
Daniel HeiseCentre of Anaesthesiology, Emergency and Intensive Care Medicine, University Hospital Göttingen, Göttingen, Germany.
Andreas Meier-HellmannDepartment of Anesthesiology and Intensive Care Medicine, HELIOS Klinikum, Erfurt, Germany.
Jörg BrederlauDepartment of Intensive Care Medicine, Helios Hospital Berlin-Buch, Berlin, Germany.
Norbert WeilerDepartment of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Gernot MarxDepartment of Intensive Care and Intermediate Care, RWTH University Hospital Aachen, Aachen, Germany.
Christian PutensenDepartment of Anesthesiology and Intensive Care Medicine, University of Bonn, Bonn, Germany.
Claudia SpiesAnaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Charité Virchow-Klinikum, Charité - University Medicine Berlin, Berlin, Germany.
Achim JörresDepartment of Medicine I - Nephrology, Transplantation & Medical Intensive Care, University Witten/Herdecke, Medical Center Cologne-Merheim, Cologne, Germany.
Michael QuintelCentre of Anaesthesiology, Emergency and Intensive Care Medicine, University Hospital Göttingen, Göttingen, Germany.
Christoph EngelInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.
John A KellumDepartment of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America.
Martin K KuhlmannDepartment of Nephrology, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Leipzig University · DEUniversitätsmedizin Göttingen · DECharité - Universitätsmedizin Berlin · DEHelios Hospital Berlin-Buch · DEHelios Klinikum Erfurt · DEKlinikum im Friedrichshain · DEUniversitätsklinikum Aachen · DEUniversity of Bonn · DEUniversity of Pittsburgh · USWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure.

methodsThis was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7.

results97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19).

conclusionsIn this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.

Indexed as

AgedCytokinesFemaleHemoperfusionHumansInterleukin-6MaleMiddle AgedSepsisCytokinesInterleukin-6

Identifiers

PMID29084247
PMCPMC5662220
OpenAlexW2766417400

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.