Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Collaborators: European Commission; Instituto de Salud Carlos III
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• Patients (≥18 years and <80 years) with a clinical diagnosis of ARDS of any aetiology (pneumonia, including SARS-CoV-2, sepsis, pancreatitis, bronchospasm and trauma) admitted to the ICU.

• Orotracheal intubation (OTI) and mechanical ventilation within 72 hours prior to randomisation.

• Moderate-severe ARDS (PaO2/FiO2: ≤200 mmHg under standardised conditions (PEEP≥5 cm H2O).

• Heart rate ≥ 60 bpm.

• Invasive systolic blood pressure ≥ 110 mmHg.

Exclusion Criteria:

• Prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation).

• Reduced left ventricular ejection fraction (LVEF <50%).

• Life expectancy due to other processes (cancer, degenerative diseases, etc.) of less than 6 months.

• Right ventricular (RV) systolic dysfunction.

• Concomitant acute heart failure (cardiac index ≤2.5 L/m2 or pulmonary capillary pressure ≥15 mmHg or clinical suspicion).

• Second-degree atrioventricular block, 2:1 AV block, high-grade/advanced AV block and third-degree AV block. Also significant sinus bradycardia, which would be implied by having a heart rate >60 bpm as an inclusion criterion.

• Pregnant or breastfeeding women.

• Cardiogenic shock.

• Persistent invasive blood pressure <110 mmHg despite vasopressor agents.

• Use of noradrenaline at concentrations greater than 0.2 µg/kg/min at the time of the randomisation.

• Use of dobutamine within 48 hours before randomisation.

• Concomitant pulmonary embolism.

• Known severe peripheral arterial disease.

• Known asthma before admission (with active bronchodilator therapy).

• Active beta-blocker treatment prior to admission (i.e. within 3 months prior to admission).