Actively Recruiting
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome Methylprednisolone vs Dexamethasone vs Hydrocortisone
Led by Fayoum University · Updated on 2025-01-06
300
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of three glucocorticoid drugs—methylprednisolone, dexamethasone, and hydrocortisone—in treating patients with acute respiratory distress syndrome (ARDS). ARDS is a severe lung condition caused by various illnesses such as pneumonia and sepsis, leading to inflammation and breathing difficulties. The study explores how these medications impact the inflammatory processes triggered in ARDS, including the role of glucocorticoid receptors and critical illness-related corticosteroid insufficiency. Participants receive one of three treatments: methylprednisolone at 1 mg/kg/day (approximately 70 mg/day), dexamethasone at 13 mg/day, or hydrocortisone at 350 mg/day. The study compares these equivalent doses to evaluate their effects on ARDS. The treatments are given during the early phase of ARDS when inflammation is most active, as this is considered the critical period for glucocorticoid intervention. During the study, researchers monitor participants closely for 28 days to assess mortality after starting treatment. Participants must be receiving mechanical ventilation for hypoxemic respiratory failure and meet specific diagnostic criteria for ARDS. The study includes chest imaging, oxygen level monitoring, and assessments of respiratory symptoms. Researchers aim to understand which glucocorticoid provides the best response in reducing inflammation and improving survival in ARDS patients.
CONDITIONS
Official Title
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving mechanical ventilation for hypoxemic respiratory failure
- Diagnosed with ARDS based on the American-European Consensus and 2012 Berlin criteria
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio of 300 mm Hg or less
- Requires supplemental oxygen to keep oxygen saturation above 93% within 48 hours of ARDS onset
- Respiratory symptoms started or worsened within 7 days
- Bilateral opacities on chest x-ray or CT not explained by other lung conditions
- Cardiac failure not the primary cause of respiratory failure
You will not qualify if you...
- Acute hypoxemic respiratory failure caused by congestive heart failure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fayoum University
Al Fayyum, Egypt
Actively Recruiting
Research Team
M
Mahmoud Ezzat Elkmash, Teaching assistant
M
Marwa Kamal Tolba, Assistant Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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