Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Launched by DR. NEGRIN UNIVERSITY HOSPITAL · Sep 5, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a medication called dexamethasone is for patients suffering from acute hypoxemic respiratory failure (AHRF) caused by infections, including COVID-19. AHRF is a serious condition where the lungs can’t get enough oxygen into the blood, and it can lead to severe illness or even death. The trial will involve adult patients who are on mechanical ventilation in intensive care units across Spain. Participants will be randomly assigned to receive either a higher or lower dose of dexamethasone for a specific period, and the main goal is to see if this treatment can reduce the risk of death within 60 days.

To be eligible for this trial, participants must be at least 18 years old, be on a ventilator, and have a specific type of lung failure linked to infections. Importantly, the trial is currently recruiting patients, so those who meet the criteria and are interested can discuss it with their healthcare team. Throughout the trial, participants will be closely monitored, and their health outcomes, including how many days they can breathe without a ventilator, will be tracked. This study aims to provide valuable insights into potential treatments for this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age 18 years or older;
• • intubated and mechanically ventilated;
• • acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
• • Pulmonary or systemic infectious etiology of AHRF.
• Exclusion Criteria:
• • Patients with a known contraindication to corticosteroids,
• • Patient included in another therapeutic clinical trial
• • Lack of informed consent