RecruitingPhase 2Phase 3NCT06496997

A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome


Sponsor

Fayoum University

Enrollment

300 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the work is to compare the efficacy of equivalent doses of methylprednisolone, dexamethasone and hydrocortisone in patients with ARDS


Eligibility

Inclusion Criteria5

  • We include patients receiving mechanical ventilation for hypoxemic respiratory failure if they met the diagnostic criteria for ARDS according to the American-European Consensus definition, as later reclassified on the basis of the 2012 Berlin criteria for the diagnosis of ARDS, defined as:
  • Presence of acute hypoxemic respiratory failure (an arterial oxygen partial pressure to fraction of inspired oxygen ratio (PaO2/FiO2) of ≤ 300 mm Hg, requiring supplemental oxygen administrated by simple face mask, nasal cannula, or other similar oxygen-delivery device to maintain oxygen saturation at greater than 93% within the first 48 h of the onset of ARDS)
  • Onset within 7 days of insult, or new (within 7 days) or worsening respiratory symptoms
  • Bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules
  • Cardiac failure not the primary cause of acute respiratory failure

Exclusion Criteria1

  • We exclude patients with acute hypoxemic respiratory failure caused by congestive heart failure

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Interventions

DRUGMethylprednisolone

Methylprednisolone at a dose of 1 mg/kg/day (an average dose of 70 mg/day based on 70 kg body weight)

DRUGDexamethasone

Dexamethasone at an equivalent dose of 13 mg/day

DRUGHydrocortisone

Hydrocortisone at an equivalent dose of 350 mg/day


Locations(1)

Fayoum University

Al Fayyum, Egypt

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NCT06496997


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