RecruitingPhase 3NCT05847517

Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the to Assess the Efficacy of Intravenous Metoprolol in Patients With Acute Respiratory Distress Syndrome (ARDS).

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Enrollment

350 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria15

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 (AV) 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).

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Interventions

DRUGMetoprolol Injection

A dilution of 15 mg Metoprolol tartrate in 100 ml saline shall be performed and infused for 10 minutes. No dose reduction or increase is allowed. Systolic blood pressure and heart rate shall be measured 3 and 6 minutes after starting the infusion. In case of a consistent drop in systolic blood pressure or heart rate, the infusion shall be stopped and the infusion noted.

DRUGsaline 0.9%

A dilution of 0.9% sodium chloride in 100 ml saline shall be performed and infused for 10 minutes. No dose reduction or increase is allowed. Systolic blood pressure and heart rate shall be measured 3 and 6 minutes after starting the infusion. In case of a consistent drop in systolic blood pressure below 110 mmHg or heart rate below 60 bpm, the infusion shall be stopped and the infusion noted.