Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT05847517

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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