Actively Recruiting
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
Led by Fayoum University · Updated on 2025-01-06
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of three glucocorticoid drugs—methylprednisolone, dexamethasone, and hydrocortisone—in patients with acute respiratory distress syndrome (ARDS). ARDS is a serious condition caused by severe inflammation in the lungs, often following pneumonia or sepsis, leading to breathing difficulties. The study aims to compare these drugs at equivalent doses to understand their impact on inflammation and lung function in ARDS patients. The study involves three groups of 100 patients each, receiving either methylprednisolone at 1 mg/kg/day, dexamethasone at 13 mg/day, or hydrocortisone at 350 mg/day. These drugs are given during the early phase of ARDS, when inflammation is most active. The study is randomized and does not use masking. Participants receive treatment and are monitored closely during a 28-day period. Participants will be assessed for outcomes such as 28-day mortality, need for invasive mechanical ventilation, number of ventilator-free days, length of ICU stay, hospitalization duration, and occurrence of serious side effects like infections and high blood sugar. The study includes chest imaging and oxygen level monitoring to confirm ARDS diagnosis and track progress. The total participation period for each patient is 28 days from enrollment.
CONDITIONS
Brief Title
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving mechanical ventilation for hypoxemic respiratory failure
- Diagnosis of ARDS by American-European Consensus and 2012 Berlin criteria
- PaO2/FiO2 ratio of 300 mm Hg or less requiring supplemental oxygen
- Onset or worsening of respiratory symptoms within 7 days
- Bilateral opacities on chest X-ray or CT not due to other lung issues
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive one of three glucocorticoid drugs to treat acute respiratory distress syndrome (ARDS).
Visits during treatment for assessments and medication administration as per protocol
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here