A Phase 3 interventional study of Metoprolol Injection and saline 0.9% in Acute Respiratory Distress Syndrome (ARDS), sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER). Terminated at 12 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Phase 3, Interventional, and Treatment
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Consorcio Centro de Investigación Biomédica en Red (CIBER) is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered IV Metoprolol tartrate 15 mg (3 ampoules of 5 ml) diluted in 100 ml of saline.
Drug: Metoprolol Injection
Participants will be administered IV saline (0.9% sodium chloride) (3 ampoules of 5 ml) diluted in 100 ml of saline.
Drug: saline 0.9%
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.
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.
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)
Time frame: 28 days
All-cause death at day 28 after randomization
cumulative incidence of death from any cause
Time frame: 28 days
Ventilator-free days at 28 days
number of days without mechanical ventilation during the firs 28 days
Time frame: 28 days
Intensive care unit days of admission
Number of days admitted at the intensive care unit
Time frame: 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.
Time frame: at 3 months
Arterial oxygenation
Mean arterial oxygen saturation (PaO2/FiO2)
Time frame: on day 8
Change in arterial oxygenation
Mean difference in arterial oxygen saturation (PaO2/FiO2) between baseline and day 8
Time frame: 8 days
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Metoprolol
Respiratory Distress Syndrome →
Consorcio Centro de Investigación Biomédica en Red (CIBER)