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RECRUITING
NCT05847517
PHASE3

Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

View on ClinicalTrials.gov

Summary

Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).

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).

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-08-13

Completion Date

2027-12

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

DRUG

Metoprolol Injection

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.

DRUG

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.

Locations (10)

Hospital Universitario de Jerez de La Frontera

Jerez de la Frontera, CADIZ, Spain

Hospital Universitario de Toledo

Toledo, Castille-La Mancha, Spain

Hospital Clinic

Barcelona, Catalonia, Spain

Hospital Parc Taulí

Barcelona, Catalonia, Spain

Fundación Jiménez Díaz University Hospital

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital de Getafe

Madrid, Madrid, Spain

Hospital General de Villalba

Madrid, Madrid, Spain

Hospital La Paz

Madrid, Madrid, Spain

Hospital Rey Juan Carlos

Madrid, Madrid, Spain