Evidence map›Paper›PMID 27449641›Full record

Trial reportTrials2016

Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial.

Jesús Villar, Javier Belda, José Manuel Añón, Jesús Blanco, Lina Pérez-Méndez, Carlos Ferrando, Domingo Martínez, Juan Alfonso Soler, Alfonso Ambrós, Tomás Muñoz and 8 more

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

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT01731795 phase4completednot on this map

A Comparative, Randomised Controlled Trial for Evaluating the Efficacy of Dexamethasone in the Treatment of Patients With Acute Respiratory Distress Syndrome

TypeinterventionalSponsorHospital Universitario de Gran Canaria Doctor NegrínRan2013 to 2019Enrolled277ConditionsAcute Respiratory Distress SyndromeArmsDexamethasone
NCT04325061 phase4terminatednot on this mapstarted 2020, after this paper: background citation

Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19

TypeinterventionalSponsorHospital Universitario de Gran Canaria Doctor NegrínRan2020 to 2020Enrolled19ConditionsAcute Respiratory Distress Syndrome Caused by COVID-19ArmsDexamethasone
NCT04540926 phase1 / phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Utility of Low Doses of Corticosteroids and Cyclosporine Combined With Enoxaparin, in Patients With COVID-19 Pneumonia at the ISSSTE Regional Hospital, Puebla, During the Contingency Period Due to the SARS-Cov2 Pandemic

TypeinterventionalSponsorInstituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoRan2020 to 2020Enrolled200ConditionsCOVID 19 PneumoniaArmsCyclosporin A
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

  1. Pharmacological agents for adults with acute respiratory distress syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Trial
  3. Article
  4. Severe COVID-19: Drugs and Clinical Trials.Journal of clinical medicine · 2023
    Review
  5. Article
  6. Glucocorticoid Therapy in COVID-19.Seminars in respiratory and critical care medicine · 2023
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Emergence of ancient convalescent plasma (CP) therapy: To manage COVID-19 pandemic.Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine · 2021
    Article
  13. Review
  14. Article
  15. Article
  16. Cytokine storms, evolution and COVID-19.Evolution, medicine, and public health · 2021
    Review
  17. Review
  18. Review
  19. Review
  20. Article
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

18 authors at 10 institutions in 3 countries.

Jesús VillarCIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.
Javier BeldaDepartment of Anesthesiology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
José Manuel AñónIntensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.
Jesús BlancoCIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
Lina Pérez-MéndezCIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
Carlos FerrandoDepartment of Anesthesiology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Domingo MartínezIntensive Care Unit, Hospital Virgen de la Arrixaca, Murcia, Spain.
Juan Alfonso SolerIntensive Care Unit, Hospital Morales Meseguer, Murcia, Spain.
Alfonso AmbrósIntensive Care Unit, Hospital General de Ciudad Real, Ciudad Real, Spain.
Tomás MuñozIntensive Care Unit, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain.
Rosana RivasIntensive care Unit, Hospital Galdakao-Usansolo, Usansolo, Vizcaya, Spain.
Ruth CorpasIntensive Care Unit, Hospital N.S. del Prado, Talavera de la Reina, Toledo, Spain.
Francisco J Díaz-DominguezIntensive Care Unit, Hospital General de León, León, Spain.
Marina SoroDepartment of Anesthesiology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Miguel Angel García-BelloBiostatistics, Research Unit, Hospital Universitario Dr. Negrín, Las Palmas, Spain.
Rosa Lidia FernándezCIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
Robert M KacmarekDepartment of Respiratory Care, Massachusetts General Hospital, Boston, MA, USA.
DEXA-ARDS Network
Instituto de Salud Carlos III · ESHospital Clínico Universitario de Valencia · ESHospital General Nuestra Señora del Prado · ESHospital General Universitario Morales Meseguer · ESHarvard University · USHospital de Galdakao · ESHospital General Universitario de Ciudad Real · ESHospital Universitario de Gran Canaria Doctor Negrín · ESHospital Virgen de la Luz · ESSt. Michael's Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough much has evolved in our understanding of the pathogenesis and factors affecting outcome of patients with acute respiratory distress syndrome (ARDS), still there is no specific pharmacologic treatment for ARDS. Several clinical trials have evaluated the utility of corticoids but none of them has demonstrated a definitive benefit due to small sample sizes, selection bias, patient heterogeneity, and time of initiation of treatment or duration of therapy. We postulated that adjunctive treatment of persistent ARDS with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and a decrease in mortality. METHODS/

designThis is a prospective, multicenter, randomized, controlled trial in 314 patients with persistent moderate/severe ARDS. Persistent ARDS is defined as maintaining a PaO2/FiO2 ≤ 200 mmHg on PEEP ≥ 10 cmH2O and FiO2 ≥ 0.5 after 24 hours of routine intensive care. Eligible patients will be randomly allocated to two arms: (i) conventional treatment without dexamethasone, (ii) conventional treatment plus dexamethasone. Patients in the dexamethasone group will be treated with a daily dose of 20 mg iv from day 1 to day 5, and 10 mg iv from day 6 to day 10. Primary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after intubation. Secondary outcome is all-cause mortality at day 60 after enrollment. DISCUSSION: This study will be the largest randomized controlled clinical trial to assess the role of dexamethasone in patients with persistent ARDS.

trial registrationRegistered on 21 November 2012 as DEXA-ARDS at ClinicalTrials.gov website ( NCT01731795 ).

Indexed as

AdultAgedAged, 80 and overAnti-Inflammatory AgentsBiasClinical ProtocolsDexamethasoneDose-Response Relationship, DrugFemaleHospital MortalityHumansKaplan-Meier EstimateMaleMiddle AgedProspective StudiesRespiration, ArtificialAnti-Inflammatory AgentsDexamethasoneAcute respiratory distress syndromeCorticoidsDexamethasoneLung-protective ventilationPositive end-expiratory pressure

Identifiers

PMID27449641
PMCPMC4957909
OpenAlexW2480489993

What OpenQuestion holds

Textmetadata
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.