HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Healthcare-Associated Pneumonia
- Sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Early Clinical Failure
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
João manoel Silva Junior
Principal Investigator
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Eligibility Criteria
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)
Arms & Interventions
Placebo
Normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit
Intervention: Placebo
Hydrocortisone
Hydrocortisone 100mg + normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit
Intervention: Hydrocortisone
Outcomes
Primary Outcomes
Early Clinical Failure
Time Frame: 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 Outcomes
- Survival(Days 7 and 28)
- Respiratory failure(7 days)
- Septic shock(7 days)
- Time of mechanical ventilation(7 days)
- Ventilator parameters (1)(7 days)
- Ventilator parameters (2)(7 days)
- Arterial blood gas analysis(7 days)
- Respiratory condition(7 days)
- Time of vasoactive drugs use(7 days)
- Length of stay(28 days)
- Need for renal substitution therapy(7 days)
- Radiological worsening(7 days)
- Adverse effects(7 days)