Status:

RECRUITING

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

Lead Sponsor:

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Collaborating Sponsors:

Instituto do Cancer do Estado de São Paulo

Hospital de Câncer de Barretos

Conditions:

Healthcare-Associated Pneumonia

Ventilator Associated Pneumonia

Eligibility:

All Genders

18+ years

Phase:

NA

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 n...

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

October 16 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2027

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT05354778

Start Date

October 16 2022

End Date

February 1 2027

Last Update

November 25 2025

Active Locations (1)

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1

Hospital do Servidor Publico Estadual

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