Testing hydrocortisone for severe hospital-acquired pneumonia in ICU patients
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
This study is testing if giving hydrocortisone to ICU patients with severe hospital-acquired pneumonia can help them get better compared to those receiving a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, Sao Paulo SP) |
| Trial ID | NCT05354778 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of hydrocortisone compared to a placebo in patients with severe hospital-acquired pneumonia who are receiving standard treatment in intensive care units. It is a multicenter, randomized, open-label trial involving 180 patients across various ICUs in Brazil. Participants will receive either intravenous hydrocortisone or a placebo every eight hours for five days, with the primary outcome being early clinical failure assessed between the third and seventh days of treatment. The study seeks to provide an inexpensive adjuvant therapy that could improve patient outcomes in critical care settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected or confirmed bacterial nosocomial pneumonia who are currently in an intensive care unit.
Not a fit: Patients with community-acquired pneumonia, viral pneumonia, or those requiring corticosteroids for other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve recovery rates for patients with severe hospital-acquired pneumonia.
How similar studies have performed: While corticosteroids have shown benefits in community-acquired pneumonia, this approach for hospital-acquired pneumonia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
São Paulo, Sao Paulo SP
- Hospital do Servidor Publico Estadual — São Paulo, Sao Paulo SP, Brazil (Recruiting)
Study contacts
- Principal investigator: João Manoel Silva Junior, MD — Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Study coordinator: Dante Raglione, MD
- Email: danraglione@gmail.com
- Phone: 5511984471792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.