NCT01731795

Brief Summary

BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the acute respiratory distress syndrome (ARDS). Great interest remains in the use of corticosteroids for the salvage of patients with severe acute lung injury in the early phase of their disease process, a situation that that has not been evaluated in most published trials. Dexamethasone has never been evaluated in ARDS in a randomized controlled fashion. HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with intravenous dexamethasone of patients with established ARDS might change the pulmonary and systemic inflammatory response and thereby will increase the number of ventilator-free days and will decrease the extremely high overall mortality. Our goal is to examine the effects of dexamethasone on length of duration of mechanical ventilation (assessed by number of ventilator-free days) and on mortality, in patients admitted into a network of Spanish intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 28, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

5.9 years

First QC Date

November 18, 2012

Last Update Submit

February 14, 2019

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Ventilator free-days

    Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated ≥28 days and for subjects who die, VFD is 0.

    28 days

Secondary Outcomes (1)

  • Mortality

    60 days

Other Outcomes (1)

  • organ failure

    ICU discharge

Study Arms (2)

No dexamethasone

NO INTERVENTION

Patients will be treated with conventional treatment

Dexamethasone

ACTIVE COMPARATOR

Conventional treatment plus dexamethasone

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily/ from Day 6 to 10 of randomization)

Also known as: Dexamethasone Indukern
Dexamethasone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old
  • Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS: (i) having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.; (ii) bilateral infiltrates on frontal chest radiograph; (iii) absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure; (iv) severe hypoxemia (a PaO2/FIO2 \<200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
  • Be intubated and mechanically ventilated
  • Have provided signed written informed consent from the patient or the patient's personal legal representative

You may not qualify if:

  • Be a woman known to be pregnant or lactating
  • Take part in another experimental treatment protocol (simultaneously)
  • Brain death
  • Terminal-stage cancer or other terminal disease
  • Having do-not-resuscitate orders
  • Being immune-compromised
  • Receiving corticosteroids or immunosuppressive drugs
  • Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
  • Have severe chronic obstructive pulmonary disease (COPD)
  • Have congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Clinico de Valencia

Valencia, Spain

Location

Related Publications (3)

  • Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.

    PMID: 32043986DERIVED

  • Sweeney RM, McAuley DF. Prolonged glucocorticoid treatment in acute respiratory distress syndrome - Authors' reply. Lancet. 2017 Apr 15;389(10078):1516-1517. doi: 10.1016/S0140-6736(17)30953-4. No abstract available.

    PMID: 28422025DERIVED

  • Villar J, Belda J, Anon JM, Blanco J, Perez-Mendez L, Ferrando C, Martinez D, Soler JA, Ambros A, Munoz T, Rivas R, Corpas R, Diaz-Dominguez FJ, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; DEXA-ARDS Network. Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial. Trials. 2016 Jul 22;17:342. doi: 10.1186/s13063-016-1456-4.

    PMID: 27449641DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jesús Villar, MD, PhD

    Research Unit, Hospital Universitario Dr. Negrín, Las Palmas, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

March 28, 2013

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)