HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: … (NCT05354778) | Clinical Trial Compass
RecruitingNot Applicable
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
Brazil180 participantsStarted 2022-10-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Clinical Failure
Timeframe: Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening
Trial details
NCT IDNCT05354778
SponsorInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo