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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 will be 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Brazil
Hospital do Servidor Publico Estadual
RECRUITING
São Paulo
Contact Information
Primary
Dante Raglione, MD
danraglione@gmail.com
5511984471792
Time Frame
Start Date: 2022-10-16
Estimated Completion Date: 2024-07
Participants
Target number of participants: 180
Treatments
Placebo_comparator: Placebo
Normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit
Active_comparator: Hydrocortisone
Hydrocortisone 100mg + normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit
Related Therapeutic Areas
Sponsors
Leads: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Collaborators: Instituto do Cancer do Estado de São Paulo, University of Sao Paulo, Hospital de Câncer de Barretos

This content was sourced from clinicaltrials.gov