Comparing glucocorticoids for treating acute respiratory distress syndrome
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
This study is testing which of three medications can best help people with acute respiratory distress syndrome who are on breathing machines to feel better and breathe easier.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT06496997 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy of three glucocorticoids—methylprednisolone, dexamethasone, and hydrocortisone—in patients diagnosed with acute respiratory distress syndrome (ARDS). ARDS is characterized by severe inflammation and respiratory failure, often following infections like pneumonia or sepsis. The study will enroll patients receiving mechanical ventilation for hypoxemic respiratory failure and will assess the impact of these glucocorticoids on inflammation and respiratory function. The research is designed to determine which glucocorticoid is most effective in managing ARDS symptoms and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients receiving mechanical ventilation for hypoxemic respiratory failure due to ARDS.
Not a fit: Patients whose acute respiratory failure is primarily due to cardiac causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from acute respiratory distress syndrome.
How similar studies have performed: Other studies have shown varying success with glucocorticoid treatments in ARDS, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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: 1. 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) 2. Onset within 7 days of insult, or new (within 7 days) or worsening respiratory symptoms 3. Bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules 4. Cardiac failure not the primary cause of acute respiratory failure Exclusion Criteria: We exclude patients with acute hypoxemic respiratory failure caused by congestive heart failure
Where this trial is running
Al Fayyum
- Fayoum University — Al Fayyum, Egypt (Recruiting)
Study contacts
- Principal investigator: Mahmoud Ezzat Elkmash, Teaching Assistant — Faculty of Pharmacy - Fayoum University
- Study coordinator: Mahmoud Ezzat Elkmash, Teaching assistant
- Email: mam54@fayoum.edu.eg
- Phone: +201094123841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.