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Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

NCT05847517 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-02-10

No results posted yet for this study

Summary

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

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

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.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    lead OTHER_GOV

Principal Investigators

  • Borja Ibanez, MD PhD FESC · CNIC & Fundación Jiménez Díaz University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2025-09-30
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05847517 on ClinicalTrials.gov