Actively Recruiting
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
Led by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Updated on 2025-02-10
350
Participants Needed
10
Research Sites
172 weeks
Total Duration
On this page
Sponsors
C
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).
CONDITIONS
Official Title
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to less than 80 years with a clinical diagnosis of ARDS from any cause admitted to the ICU
- Orotracheal intubation and mechanical ventilation within 72 hours before randomisation
- Moderate to severe ARDS with PaO2/FiO2 ratio less than or equal to 200 mmHg under standardized conditions (PEEP at least 5 cm H2O)
- Heart rate of 60 beats per minute or higher
- Invasive systolic blood pressure of 110 mmHg or higher
You will not qualify if you...
- Hospital admission lasting 7 days or more before randomisation
- Left ventricular ejection fraction below 50%
- Life expectancy less than 6 months due to other diseases such as cancer or degenerative conditions
- Right ventricular systolic dysfunction
- Acute heart failure or related clinical suspicion
- Second-degree or higher atrioventricular block or significant sinus bradycardia
- Pregnant or breastfeeding women
- Cardiogenic shock
- Persistent invasive blood pressure below 110 mmHg despite vasopressor use
- Use of noradrenaline above 0.2 micrograms/kg/min at randomisation
- Use of dobutamine within 48 hours before randomisation
- Pulmonary embolism
- Known severe peripheral arterial disease
- Known asthma with active bronchodilator treatment before admission
- Use of beta-blocker treatment within 3 months before admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Hospital Universitario de Jerez de La Frontera
Jerez de la Frontera, CADIZ, Spain
Active, Not Recruiting
2
Hospital Universitario de Toledo
Toledo, Castille-La Mancha, Spain
Not Yet Recruiting
3
Hospital Clinic
Barcelona, Catalonia, Spain
Active, Not Recruiting
4
Hospital Parc Taulí
Barcelona, Catalonia, Spain
Not Yet Recruiting
5
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, Spain
Actively Recruiting
6
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Active, Not Recruiting
7
Hospital de Getafe
Madrid, Madrid, Spain
Not Yet Recruiting
8
Hospital General de Villalba
Madrid, Madrid, Spain
Active, Not Recruiting
9
Hospital La Paz
Madrid, Madrid, Spain
Active, Not Recruiting
10
Hospital Rey Juan Carlos
Madrid, Madrid, Spain
Actively Recruiting
Research Team
M
Marta Delgado
CONTACT
P
Projects Department (CIBER)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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