A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome

NCT06496997 | Recruiting Phase 2

• 1 other identifier: Steroids Efficacy in ARDS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 28-day mortality after enrolment

  From enrollment to the end of treatment at 28 days

Secondary Outcomes (5)

• The number of patients needing invasive mechanical ventilation

  From enrollment to the end of treatment at 28 days

• The Number of ventilator-free days

  From enrollment to the end of treatment at 28 days

• Duration of the ICU stay

  From enrollment to the end of treatment at 28 days

• Duration of hospitalization

  From enrollment to the end of treatment at 28 days

• Incidence of serious adverse events, including secondary infections, hyperglycemia, clinically important gastrointestinal bleeding, and hypertension

  From enrollment to the end of treatment at 28 days

Study Arms (3)

Group 1

EXPERIMENTAL

100 ARDS patients

Drug: Methylprednisolone

Group 2

EXPERIMENTAL

100 ARDS patients

Drug: Dexamethasone

Group 3

EXPERIMENTAL

100 ARDS patients

Drug: Hydrocortisone

Interventions

Methylprednisolone DRUG

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

Group 1

Dexamethasone DRUG

Dexamethasone at an equivalent dose of 13 mg/day

Group 2

Hydrocortisone DRUG

Hydrocortisone at an equivalent dose of 350 mg/day

Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Methylprednisolone; Dexamethasone; Hydrocortisone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Mahmoud Ezzat Elkmash, Teaching Assistant

  Faculty of Pharmacy - Fayoum University

  PRINCIPAL INVESTIGATOR

• Raghda Roshdy Hussein, Assistant Professor

  Faculty of Pharmacy - Beni Suef University

  STUDY DIRECTOR

• Marwa Kamal Tolba, Assistant Professor

  Faculty of Pharmacy - Fayoum University

  STUDY DIRECTOR

• Marian Sobhi Saeed, Lecturer

  Faculty of Pharmacy - Beni Suef University

  STUDY DIRECTOR

• Mona Ibrahim Ahmed, Lecturer

  Faculty of Medicine - Fayoum University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Ezzat Elkmash, Teaching assistant

CONTACT

+201094123841; mam54@fayoum.edu.eg

Marwa Kamal Tolba, Assistant Professor

CONTACT

+201067789982; mka05@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in Clinical Pharmacy Department-Faculty of Pharmacy-Fayoum University

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

EG (1)