In-hospital acquired sepsis Septic shock Hypotension Hydrocortisone Corticosteroids Critical illness Adrenal insufficiency Diabetes mellitus Personalized medicine
Conditions
Interventions
Patients will receive a 50 mg intravenous bolus of hydrocortisone every 6 hours, followed by a continuous intravenous infusion of 200 mg per day for a total duration of 48 hours.,Patients will receive
Experimental Drug,Placebo Comparator Drug
Hydrocortisone,Placebo
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1.Age greater than or equal to 18 years 2.In-hospital onset of suspected or confirmed sepsis after greater than or equal to 72 hours of hospital admission 3.Sepsis-induced hypotension, defined as Mean Arterial Pressure (MAP) less than 65 mmHg for greater than or equal to 15 minutes despite initial fluid resuscitation 4.Sepsis defined according to Sepsis-3 criteria (Suspected/documented infection and acute increase in SOFA score greater than or equal to 2)
Exclusion criteria
Exclusion criteria: 1.Prior systemic corticosteroid use (hydrocortisone/prednisolone within 24 hours, or dexamethasone within 5 days) 2.Specific indications for corticosteroids independent of sepsis 3.Known primary adrenal insufficiency or other chronic endocrine disorders 4.Identification of other non-septic causes of shock 5.Presence of hyperglycemic crisis (DKA or HHS) at enrollment 6.Confirmed pregnancy 7.Advanced chronic liver disease (Child-Pugh Class C) 8.Documented do-not-resuscitate (DNR) order or palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to shock reversal Up to 28 days Duration in hours from study drug start to cessation of all vasopressors for at least 6 consecutive hours with MAP at least 65 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality Day 28 The proportion of patients who died from any cause within 28 days after randomization.,Ventilator free days at day 28 Day 28 Number of days alive and free from mechanical ventilation within the first 28 days.,ICU length of stay Up to hospital discharge The duration in days from ICU admission to ICU discharge. | — |
Countries
Thailand
Contacts
Public ContactSutthinee Boonmee
Siriraj Hospital, Mahidol University
Outcome results
None listed