HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
Launched by INSTITUTO DE ASSISTENCIA MEDICA AO SERVIDOR PUBLICO ESTADUAL, SAO PAULO · Apr 26, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The HYDRO-SHIP Study is a clinical trial looking at whether hydrocortisone, a type of steroid medication, can help improve outcomes for patients with severe pneumonia that they acquired while in the hospital. This study is important because while steroids have been shown to help patients with pneumonia caught outside of the hospital, there hasn't been much research on their effectiveness for hospital-acquired pneumonia. By testing hydrocortisone along with standard treatments, researchers hope to see if it can lower the risk of death for these critically ill patients.
To participate in this trial, you need to be at least 18 years old and have pneumonia that was acquired in the hospital, along with being in the Intensive Care Unit (ICU). You’ll need to give your consent, or have a legal guardian do so, to join the study. This trial is currently recruiting participants, and it is open to all genders. If you qualify and choose to participate, you will receive either hydrocortisone or a placebo (a treatment that looks like the real thing but has no active ingredients) alongside your regular care. The study aims to find out if adding hydrocortisone can make a difference in patient recovery, and it is considered safe with manageable side effects.
Gender
ALL
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)
About Instituto De Assistencia Medica Ao Servidor Publico Estadual, Sao Paulo
The Instituto de Assistência Médica ao Servidor Público Estadual (IAMSP) in São Paulo is a prominent healthcare institution dedicated to providing comprehensive medical care and support to public servants and their families. As a clinical trial sponsor, IAMSP is committed to advancing medical research and improving healthcare outcomes through rigorous clinical studies. The institute prioritizes ethical standards, patient safety, and scientific integrity, collaborating with healthcare professionals and researchers to facilitate innovative therapies and treatments that address the evolving needs of the population it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, Sao Paulo Sp, Brazil
Patients applied
Trial Officials
João Manoel Silva Junior, MD
Principal Investigator
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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