Healthcare-Associated Pneumonia
Conditions
Interventions
Multicenter, randomized, open-label clinical trial, composed by two groups: hydrocortisone and placebo. Both groups will receive the standard treatment for hospital-acquired pneumonia. Intravenous hyd
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age or older; Suspected or confirmed case of bacterial nosocomial pneumonia (including ventilator-associated pneumonia); Intensive Care Unit stay; Signed consent form (by the patient or a legal guardian)
Exclusion criteria
Exclusion criteria: Women who are pregnant, have recently given birth or are breastfeeding; Patients who are moribund or do not have a treatment perspective; Patients with community acquired pneumonia; Patients with other types of pneumonia; Those with pulmonary infiltrates in chest image which are not compatible with bacterial pneumonia; Patients with adrenal insufficiency; Patients who have a condition that demands the use of corticosteroids (acute or chronic); Patients allergic to hydrocortisone; Patients with refractory septic shock (those receiving more than 0,5mcg/kg/min of norepinephrine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect a composed outcome which will be called early clinical failure, defined by at least one of the following criteria: death in the first seven days after recruitment and hemodynamic or respiratory worsening between day 3 and day 7. Hemodynamic worsening will be defined by the beginning or increased need of vasoactive drugs. Respiratory worsening will be defined by the need of orotracheal intubation or increase in ventilatory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival in 7 and 28 days, obtained by survival analysis curve and log-rank test;Respiratory failure, defined as the need for mechanical ventilation and intubation daily;Septic shock, defined as the daily need for vasoactive drugs when dealing with the infection;Time of mechanical ventilation after intubation obtained in days and ventilation parameters, such as PEEP, FiO2, obtained daily;Length of stay (ICU and hospital), defined in number of days;Need for renal substitution therapy, defined by the need of hemodialysis in the ICU;Radiological worsening, measured by periodic chest X-rays and appearance of new pulmonary infiltrates;Adverse effects, such as intestinal bleeding, hypernatremia, hypokalemia, hyperglycemia, obtained from laboratory exams, and clinical events such as delirium and insomnia | — |
Countries
Brazil
Contacts
Public ContactJoão Silva Junior
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed