The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Mervyn Singer, Clifford S Deutschman, Christopher Warren Seymour...
https://pubmed.ncbi.nlm.nih.gov/26903338Actively Recruiting
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
I
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Lead Sponsor
I
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsor
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
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Hospital do Servidor Publico Estadual
São Paulo, Sao Paulo SP, Brazil, 04039-901
Actively Recruiting
D
Dante Raglione, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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