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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
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.
Hospital Universitario de Jerez de La Frontera
Jerez de la Frontera, CADIZ, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario de Toledo
Toledo, Castille-La Mancha, Spain
NOT_YET_RECRUITINGHospital Clinic
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
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Barcelona, Catalonia, Spain
Hospital Parc Taulí
Barcelona, Catalonia, Spain
NOT_YET_RECRUITINGFundación Jiménez Díaz University Hospital
Madrid, Madrid, Spain
RECRUITINGHospital Clínico San Carlos
Madrid, Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital de Getafe
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital General de Villalba
Madrid, Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital La Paz
Madrid, Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Rey Juan Carlos
Madrid, Madrid, Spain
RECRUITINGMean difference in arterial oxygen saturation (PaO2/FiO2) between baseline and day 8
Time frame: 8 days