Actively Recruiting

Phase 2
Phase 3
All Genders
ID06496997

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Frequently Asked Questions

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A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome Methylprednisolone vs Dexamethasone vs Hydrocortisone | DecenTrialz