Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05354778

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

8 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

Researchers are studying the use of hydrocortisone, a corticosteroid, in patients who have severe hospital-acquired pneumonia requiring intensive care. This bacterial infection can be deadly, and while corticosteroids have been shown to reduce death rates in severe community pneumonia, there are no previous studies on their use in hospital-acquired pneumonia. This trial is the first multicenter randomized study to evaluate hydrocortisone alongside standard therapy for this condition. The study randomly assigns 180 intensive care patients with nosocomial pneumonia to receive either hydrocortisone or a placebo, both along with standard treatment. Participants receive an intravenous dose of 100mg hydrocortisone or normal saline every eight hours for up to five days, or until they leave the ICU or pass away. The trial is conducted in multiple ICUs across Brazil and compares outcomes between the two groups. Participants will be closely monitored for early clinical failure, survival rates, respiratory and cardiovascular worsening, need for mechanical ventilation or dialysis, length of hospital and ICU stays, and any adverse effects. Various assessments including radiological imaging and arterial blood gas analysis will be done over a 7 to 28-day period. This study aims to provide important insights into an affordable treatment option that may improve patient outcomes in intensive care settings.

CONDITIONS

Brief 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
  • Currently staying in an Intensive Care Unit
  • Signed consent form by the patient or a legal guardian
Not Eligible

You will not qualify if you...

  • Women who are pregnant, have recently given birth, or are breastfeeding
  • Patients who are moribund or have no treatment perspective
  • Patients with community-acquired pneumonia
  • Patients with other types of pneumonia such as viral (including COVID-19) or fungal
  • Patients with pulmonary infiltrates not compatible with bacterial pneumonia
  • Patients with adrenal insufficiency
  • Patients requiring corticosteroids for other conditions
  • Patients allergic to hydrocortisone
  • Patients with refractory septic shock receiving high doses of norepinephrine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 5 days or until discharge from the intensive care unit or death

Participants receive hydrocortisone or placebo along with standard therapy for nosocomial pneumonia in the intensive care unit.

Multiple dosing every 8 hours during treatment period

Follow-up

Duration - Up to 28 days after treatment start

Participants are monitored for survival, respiratory and cardiovascular status, and adverse effects after treatment.

Visits at days 7 and 28

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

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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Frequently Asked Questions

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Published Research Related To This Trial

Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock.

Djillali Annane, Véronique Sébille, Claire Charpentier...

https://pubmed.ncbi.nlm.nih.gov/12186604

Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency (CIRCI) in Critically Ill Patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017.

Djillali Annane, Stephen M Pastores, Bram Rochwerg...

https://pubmed.ncbi.nlm.nih.gov/28938253

Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.

WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Jonathan A C Sterne, Srinivas Murthy...

https://pubmed.ncbi.nlm.nih.gov/32876694

Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial.

Claudine Angela Blum, Nicole Nigro, Matthias Briel...

https://pubmed.ncbi.nlm.nih.gov/25608756