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Efficacy Study of Dexamethasone to Treat the Acute Respiratory Distress Syndrome

NCT01731795 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2019-02-18

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Dexamethasone

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)

Sponsors & Collaborators

  • Fundación Mutua Madrileña

    collaborator OTHER

  • Asociación Científica Pulmón y Ventilación Mecánica

    collaborator OTHER

  • Dr. Negrin University Hospital

    lead OTHER

Principal Investigators

  • Jesús Villar, MD, PhD · Research Unit, Hospital Universitario Dr. Negrín, Las Palmas, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2019-02-12
Completion
2019-02-12

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731795 on ClinicalTrials.gov