Patients with sepsis-induced hypotension or septic shock in the emergency department Sepsis Septic shock Hydrocortisone
Conditions
Interventions
For the EH group, 50 mg of hydrocortisone in 10 ml of normal saline will be given as an intravenous bolus, then 200 mg of hydrocortisone in 100 ml of normal saline will be given as continuous intraven
Early intravenous hydrocortisone (EH group),Usual care
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult > 18 years 2. Suspected or definite sepsis 3. Hypotension (mean arterial pressure < 65 mmHg)
Exclusion criteria
Exclusion criteria: 1. Randomization occurred later than 3 hours after the onset of hypotension 2. Causes of shock other than sepsis identified 3. Immunocompromised 4. Hyperglycemic crisis (diabetic ketoacidosis, hyperosmolar hyperglycemic state) 5. Pregnancy 6. Post-cardiac arrest 7. Systemic corticosteroids indicated for other conditions 8. Received systemic corticosteroids within 4 weeks at any dose 9. Cancer patients who are receiving palliative treatment 10. Do-not-resuscitate order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day mortality At 28 days after randomization Mortality status at 28-d after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to shock control Within admission Time (hours) from randomization to shock control (MAP greater or equal to 65 mm Hg for at least 30 minutes with evidence of adequate tissue perfusion),In-hospital mortality At hospital discharge Mortality status at hospital discharge,Hospital length of stay At hospital discharge Time from randomization to hospital discharge (days),Ventilator-free day At 28 days after randomization the number of days that patients were alive and free of ventilators up to day 28,Vasopressor-free day At 28 days after randomization the number of days that patients were alive and free of vasopressors up to day 28,The use of RRT At hospital discharge Newly initiation of RRT in any modes, or the initiation sustained low-efficiency dialysis (SLED) or continuous RRT (CRRT) in previously hemodialysis patients,The highest vasopressor dose At hospital discharge Norepinephrine-equivalent dose (mcg/kg/min) | — |
Countries
Thailand
Contacts
Public ContactChairat Permpikul
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed