Study on the Effects of Metoprolol in Patients with Acute Respiratory Distress Syndrome (ARDS)

3 1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition that affects the lungs, making it difficult to breathe. The trial will investigate the effects of a medication called metoprolol tartrate, which is administered as a solution for injection. Metoprolol tartrate is commonly used to treat heart-related conditions, but this study aims to explore its potential benefits for patients with ARDS.

The purpose of the study is to evaluate how well metoprolol tartrate works in helping patients with ARDS. Participants in the study will receive either the medication or a placebo. The study will monitor participants over a period of 28 days to see how many days they are alive and free from the need for a machine to help them breathe, known as invasive mechanical ventilation. The study will also look at other outcomes, such as the number of days spent in the intensive care unit and overall quality of life after three months.

Throughout the study, researchers will collect information on various health indicators, including the level of oxygen in the blood. This will help determine if metoprolol tartrate can improve the condition of patients with ARDS. The trial is designed to provide valuable insights into the potential use of this medication for treating ARDS and improving patient outcomes.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives the study medication, and the other receives a placebo, which is a substance with no active medication. This process is done to compare the effects of the medication with no treatment.

2 medication administration

Participants in the medication group receive Beloken 1 mg/ml solution for injection, which contains the active substance metoprolol tartrate. This medication is administered intravenously, meaning it is given through a vein.

The dosage and frequency of administration are determined by the study protocol and are monitored by healthcare professionals.

3 monitoring and assessments

Participants are closely monitored throughout the study. This includes regular checks of vital signs such as heart rate and blood pressure, as well as assessments of respiratory function.

The primary goal is to evaluate the number of days participants are alive and free of mechanical ventilation during the first 28 days.

4 follow-up evaluations

Secondary evaluations include checking the overall survival rate at 28 days, the number of days without mechanical ventilation, and the number of days spent in the intensive care unit over a period of three months.

Quality of life is assessed using a questionnaire called the ‘Short Form 36 Health Survey Questionnaire’ (SF-36), which measures various aspects of health status.

5 end of study participation

The study concludes after the final assessments are completed. Participants may be asked to attend a final visit to discuss their experience and any ongoing care needs.

The estimated end date for the study is December 1, 2027.

Who Can Join the Study?

Patients must be between 18 and 79 years old.
Must have a clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS) from any cause, such as pneumonia (including SARS-CoV-2), sepsis, pancreatitis, bronchospasm, or trauma, and must be admitted to the Intensive Care Unit (ICU).
Must have had orotracheal intubation (a tube placed through the mouth into the windpipe) and be on mechanical ventilation (a machine helping with breathing) within 72 hours before being chosen for the study.
Must have moderate to severe ARDS, which means a specific measurement of blood oxygen levels (PaO2/FiO2) is 200 mmHg or less under certain conditions (with a PEEP of 5 cm H2O or more). PEEP stands for Positive End-Expiratory Pressure, a setting on the ventilator.
Must have a heart rate of at least 60 beats per minute (bpm).
Must have an invasive systolic blood pressure of at least 110 mmHg. This is a measurement of blood pressure taken directly from inside the arteries.

Who Cannot Join the Study?

Patients who are not experiencing Acute Respiratory Distress Syndrome (ARDS) cannot participate. ARDS is a severe lung condition that causes difficulty in breathing.
Patients who are part of a vulnerable population are not eligible. This means individuals who might need special protection or care, such as those with certain disabilities or those who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Jerez Puerta Del Sur Grupo Hla S.A.	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Htlpcbke Ujmbizzghlppu Dp Li Ppwhsikz	Madrid	Spain
Ptys Tmlfu Hcunehve Ukjpsnwwtfnt	Sabadell	Spain
Fgqnffbup Pbvb Lc Iubnksfpjpvxf Bkzmxfiwg Deh Huhrisgz Ujvbnscgdjezu Lw Phy	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.11.2023

Trial locations

Investigated drugs:

Metoprolol Tartrate

Metoprolol is a medication that is being tested in this clinical trial to see if it can help patients with Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition where the lungs cannot provide enough oxygen to the body’s organs. Metoprolol is usually used to treat high blood pressure and heart problems, but in this trial, it is given through an IV to see if it can improve lung function and help patients breathe better without the need for a machine. The goal is to see if metoprolol can help patients live longer and spend fewer days on a ventilator during the first 28 days of treatment.

Investigated diseases:

Acute respiratory distress syndrome

Acute Respiratory Distress Syndrome (ARDS) – This condition is characterized by rapid onset of widespread inflammation in the lungs. It leads to fluid accumulation in the air sacs, which results in severe breathing difficulties. The disease progresses as the lungs become stiff, reducing their ability to expand and contract. This stiffness impairs oxygen exchange, causing low blood oxygen levels. As ARDS advances, patients may require mechanical ventilation to support breathing. The condition can develop quickly and requires close monitoring.

Trial ID:

2024-515813-17-00

NCT ID:

NCT05847517

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Metoprolol in Patients with Acute Respiratory Distress Syndrome (ARDS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?