Hydrocortisone versus placebo for severe Hospital Pneumonia in ICU patients

Phase 3

Recruiting

• Conditions: Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

• Registration Number: RBR-9th6k46
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-15
• Last Update Posted: 29 May 2023
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We expect a composed outcome which will be called early clinical failure, between the third and the seventh day after the beginning of the therapy, as defined by at least one of the following criteria: death, hemodynamic worsening or respiratory worsening. Death will be defined if the patient dies in that period. 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 Outcome Measures

Name	Time	Method
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;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;Survival in 7 and 28 days, obtained by survival analysis curve and log-rank test;Time of mechanical ventilation after intubation obtained in days and ventilation parameters, such as PEEP, FiO2, obtained daily;Septic shock, defined as the daily need for vasoactive drugs when dealing with the infection;Respiratory failure, defined as the need for mechanical ventilation and intubation daily