Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05354778

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

Led by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo · Updated on 2025-11-25

180

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

Sponsors

I

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Lead Sponsor

I

Instituto do Cancer do Estado de São Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Suspected or confirmed bacterial nosocomial pneumonia, including ventilator-associated pneumonia
  • Stay in an intensive care unit
  • Signed consent form by the patient or legal guardian
Not Eligible

You will not qualify if you...

  • Women who are pregnant, recently gave birth, or are breastfeeding
  • Patients who are moribund or have no treatment options
  • Patients with community-acquired pneumonia
  • Patients with other types of pneumonia, including viral (COVID-19) or fungal
  • Pulmonary infiltrates on chest imaging not matching bacterial pneumonia
  • Patients with adrenal insufficiency
  • Patients requiring corticosteroids for any condition, acute or chronic
  • Patients allergic to hydrocortisone
  • Patients with refractory septic shock receiving high-dose norepinephrine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital do Servidor Publico Estadual

São Paulo, Sao Paulo SP, Brazil, 04039-901

Actively Recruiting

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Research Team

D

Dante Raglione, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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