Healthcare-Associated Pneumonia, Ventilator Associated Pneumonia
Conditions
Keywords
Hydrocortisone, Intensive Care Unit, Pneumonia, Steroids, Critical Care
Brief summary
The use of corticosteroids in patients with severe community pneumonia, bacterial infection which kills lots of patients around the world, reduces the mortality of this infection. However, there are no studies with this type of drug regarding hospital-acquired pneumonia. This is the first multicenter randomized trial to test hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia. This intervention is inexpensive and may improve the outcome of those patients, besides having an acceptable side effects profile.
Detailed description
Introduction and Objectives: the use of corticosteroids in patients with severe community pneumonia reduces morbimortality. However, to our knowledge, there are no studies with steroids for patients in intensive care with nosocomial pneumonia, among which those with ventilator associated pneumonia, infections which carry a high mortality rate. The treatment for those diseases involves intensive care and antibiotics, but there is a need for inexpensive, adjuvant therapies which improve the outcome for those patients. Therefore, the objective of this study is to compare hydrocortisone versus placebo, both with standard therapy, in the outcome of critical care patients diagnosed with nosocomial pneumonia. Methods: multicenter randomized, open-label, controlled trial, with two parallel groups: hydrocortisone or placebo, associated with nosocomial pneumonia's standard treatment. Patients with viral or other etiologies of pneumonia are excluded, as well as corticosteroids chronical users, or patients with conditions which demand this type of therapy. Intravenous 100mg of hydrocortisone and normal saline (the placebo) are tested every eight hours for five days or until intensive care unit (ICU) discharge or until the patient dies. The sample is 180 patients, 90 in each group, in different ICUs in Brazil. The primary outcome is early clinical failure. The secondary outcomes are survival and mortality in both groups, need for intubation, mechanical ventilation, vasoactive drugs and dialysis, lengths of stay in the hospital and in the ICU, radiological progression and adverse events. Discussion, risks, and benefits: this is the first multicenter randomized trial to test hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia. This intervention is inexpensive and may improve the outcome of those patients, besides having an acceptable side effects profile. Weighing the benefits and risks of this study, as well as its strengths and potential weaknesses, it is believed that its realization is justified, in addition to bringing important advances in the field of intensive care.
Interventions
DRUGHydrocortisone
Corticosteroid
DRUGPlacebo
Normal saline only
Sponsors
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Instituto do Cancer do Estado de São Paulo
Hospital de Câncer de Barretos
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a multicenter, randomized, open-label clinical trial with two parallel groups: hydrocortisone and placebo. Data analyzed as "intention-to-treat".
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Suspected ou 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 (viral - including COVID-19, fungal etc.) * 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 | Description |
|---|---|---|
| Early Clinical Failure | Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening | Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Days 7 and 28 | In the intensive care unit and in the hospital |
| Respiratory failure | 7 days | Need for mechanical ventilation |
| Septic shock | 7 days | Need for vasoactive drugs |
| Time of mechanical ventilation | 7 days | Number of days patients require invasive ventilation support |
| Ventilator parameters (1) | 7 days | Positive end expiratory pressure (PEEP) |
| Ventilator parameters (2) | 7 days | Inspired oxygen fraction (FiO2) |
| Arterial blood gas analysis | 7 days | Partial pressure of oxygen (PaO2) |
| Respiratory condition | 7 days | Horowitz index for lung function (P/F ratio) - obtained from PaO2/FiO2 |
| Time of vasoactive drugs use | 7 days | Dosage and types of vasoactive drugs |
| Length of stay | 28 days | In the Intensive Care Unit and in the hospital |
| Need for renal substitution therapy | 7 days | Need for dialysis |
| Radiological worsening | 7 days | Progression of image in the chest X-ray image |
| Adverse effects | 7 days | psychosis, insomnia, hyperglycemia, hypernatremia, rhabdomyolysis, gastrointestinal bleeding and critical myopathy illness |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORJoão Manoel Silva Junior, MD
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Outcome results
None listed