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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrocortisone

    Drug

    Corticosteroid

  • Placebo

    Drug

    Normal saline only

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: HydrocortisoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early Clinical Failure

Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening

Time frame
Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening

Secondary outcomes

1

Survival

In the intensive care unit and in the hospital

Time frame
Days 7 and 28
2

Respiratory failure

Need for mechanical ventilation

Time frame
7 days
3

Septic shock

Need for vasoactive drugs

Time frame
7 days
4

Time of mechanical ventilation

Number of days patients require invasive ventilation support

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Collaborator

Hospital de Câncer de Barretos

Collaborator

University of Sao Paulo

Collaborator