Acute Respiratory Distress Syndrome (ARDS)Phase 3MAIDENNCT05847517
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
A Phase 3 study testing Metoprolol Injection and saline 0.9% in people with Acute Respiratory Distress Syndrome (ARDS), run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 12 sites in Spain.
Trial summary
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Metoprolol Injection and saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 12 sitesSpain
- Study dates
- 10 Jul 2024to 6 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Consorci Corporació Sanitària Parc Taulí
Barcelona, Catalonia, 08208
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario General de Villalba
Madrid, 28400
Hospital Universitario de Getafe
Madrid, 28905
Hospital Universitario Rey Juan Carlos
Madrid, 28933
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Complejo Hospitalario Universitario de Toledo
Toledo, Castille-La Mancha, 45007
Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: 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).
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).
Read the detailed description
This is a placebo-controlled, randomised, double-blind, multicentre, Phase III clinical trial to assess the efficacy of IV metoprolol in newly intubated ARDS patients, assessing survival and days free of invasive mechanical ventilation during the first 28 days. Eligible participants shall have had 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), a heart rate ≥ 60 bpm and invasive systolic blood pressure ≥ 110 mmHg.The trial will include a total of n=350 patients, with two treatment arms: metoprolol vs. placebo (1:1). Each of the 7 days of treatment, participants will be receive 15 mg of iv metoprolol tartrate or matching placebo in 100 ml of saline for 10 minutes.
- Being tested
- Metoprolol Injection, saline 0.9%
- Keywords
- metoprolol, beta-blockers, sepsis, orotracheal intubation, Pathologic Processes, Respiratory Disease, Neutrophil Extracellular Traps, platelet aggregation, diffuse alveolar damage, neutrophil infiltration, Pulmonary Inflammation, pancreatitis, Severe Acute Respiratory Syndrome-Corona Virus-2, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis, Pathologic Processes, Respiration Disorders, Pneumonia, Pancreatitis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol InjectionDrug
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.
saline 0.9%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol | Active comparator | Participants will be administered IV Metoprolol tartrate 15 mg (3 ampoules of 5 ml) diluted in 100 ml of saline. Receives: Drug: Metoprolol Injection |
| Saline | Placebo comparator | Participants will be administered IV saline (0.9% sodium chloride) (3 ampoules of 5 ml) diluted in 100 ml of saline. Receives: Drug: saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
days alive and free of invasive mechanical ventilation during the first 28 days.
Hierarchical composite outcome "Alive and ventilator-free days at 28 days" (win ratio approach)
Measured: 28 days
Secondary outcomes (6)
All-cause death at day 28 after randomization
cumulative incidence of death from any cause
Measured: 28 days
Ventilator-free days at 28 days
number of days without mechanical ventilation during the firs 28 days
Measured: 28 days
Intensive care unit days of admission
Number of days admitted at the intensive care unit
Measured: 3 months
Quality of life score
Mean quality of life score according to ''The Short Form 36 Health Survey Questionnaire'' (SF-36). The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Measured: at 3 months
Arterial oxygenation
Mean arterial oxygen saturation (PaO2/FiO2)
Measured: on day 8
Change in arterial oxygenation
Mean difference in arterial oxygen saturation (PaO2/FiO2) between baseline and day 8
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start10 Jul 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Why it stopped: Persistently low recruitment of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization (1:1) will be stratified according to the severity of ARDS and by participating centre: * Moderate (PaO2/FiO2 of 100-200 mmHg). * Severe (PaO2/FiO2 ≤100 mmHg).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- European Commission, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Borja Ibanez, MD PhD FESC, Principal investigator, CNIC & Fundación Jiménez Díaz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847517
- Sponsor's protocol ID
- MAIDEN
- Acronym
- MAIDEN
- Status last verified
- May 2026
- First submitted
- 21 Apr 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05847517
- Acronym / sponsor ID
- MAIDEN / MAIDEN
- Keywords
- metoprolol, beta-blockers, sepsis, orotracheal intubation, Pathologic Processes, Respiratory Disease, Neutrophil Extracellular Traps, platelet aggregation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Persistently low recruitment of subjects
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- European Commission, Instituto de Salud Carlos III
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).
Detailed description
This is a placebo-controlled, randomised, double-blind, multicentre, Phase III clinical trial to assess the efficacy of IV metoprolol in newly intubated ARDS patients, assessing survival and days free of invasive mechanical ventilation during the first 28 days. Eligible participants shall have had 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), a heart rate ≥ 60 bpm and invasive systolic blood pressure ≥ 110 mmHg.The trial will include a total of n=350 patients, with two treatment arms: metoprolol vs. placebo (1:1). Each of the 7 days of treatment, participants will be receive 15 mg of iv metoprolol tartrate or matching placebo in 100 ml of saline for 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization (1:1) will be stratified according to the severity of ARDS and by participating centre: * Moderate (PaO2/FiO2 of 100-200 mmHg). * Severe (PaO2/FiO2 ≤100 mmHg).
| Arm | Type | Receives |
|---|---|---|
| Metoprolol | Active comparator | Drug: Metoprolol InjectionParticipants will be administered IV Metoprolol tartrate 15 mg (3 ampoules of 5 ml) diluted in 100 ml of saline. |
| Saline | Placebo comparator | Drug: saline 0.9%Participants will be administered IV saline (0.9% sodium chloride) (3 ampoules of 5 ml) diluted in 100 ml of saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol InjectionA 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. | Drug | Metoprolol |
| saline 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. | Drug | Saline |
Primary outcome
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)
6 secondary outcomes
All-cause death at day 28 after randomization
Time frame: 28 days
Ventilator-free days at 28 days
Time frame: 28 days
Intensive care unit days of admission
Time frame: 3 months
Quality of life score
Time frame: at 3 months
Arterial oxygenation
Time frame: on day 8
Change in arterial oxygenation
Time frame: 8 days
Results and safety
The study was stopped early (reason given: Persistently low recruitment of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borja Ibanez, MD PhD FESC principal investigator
CNIC & Fundación Jiménez Díaz University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoprolol Injection and saline 0.9% in people with Acute Respiratory Distress Syndrome (ARDS), run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Persistently low recruitment of subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days alive and free of invasive mechanical ventilation during the first 28 days. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.