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Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN) — MAIDEN  

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

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).

Clinical 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05847517
Study type Interventional
Source Consorcio Centro de Investigación Biomédica en Red (CIBER)
Contact Elba Barroso Fuentes, BS
Phone +34 91 550 48 00
Email maiden.elba.barroso@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date November 2023
Completion date December 2027
View Details
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