HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

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.

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)