Efficacy Study of Dexamethasone to Treat the Acute Respiratory Distress Syndrome

• Status: Completed
• Trial end date: 2019-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Negrin University Hospital
• Collaborators: Asociación Científica Pulmón y Ventilación Mecánica; Fundación Mutua Madrileña
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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