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Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
EU CTIS ID: 2024-515813-17-00
What this study is testing
Days alive and free of invasive mechanical ventilation during the first 28 days. [ Time Frame: 28 days ] Hierarchical composite outcome "Alive and ventilator-free days at 28 days" (win ratio approach)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation).
- 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).
See the full eligibility 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.
- Prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation).
- 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).
- Reduced left ventricular ejection fraction (LVEF <50%).
- Life expectancy due to other processes (cancer, degenerative diseases, etc.) of les tan 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 inclusión criterion.
- Pregnant or breastfeeding women.
- Cardiogenic shock.
- Persistent invasive blood pressure <110 mmHg despite vasopresor agents.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.