Early Intravenous Hydrocortisone in Sepsis
Early Intravenous Hydrocortisone in Sepsis: a Randomized Control Trial
Siriraj Hospital
230 participants
Jun 25, 2024
INTERVENTIONAL
Summary
The goal of this clinical trial is to compare two timings of steroid treatment in patients with severe infection who develop low blood pressure. The main question it aims to answer is: • Which timing strategy is better between starting steroid treatment very early in the course of severe infection, or waiting until the patient does not respond to medicine that raises blood pressure according to the current guidelines? Participants will receive either early steroid treatment or placebo right after they develop low blood pressure from infection. Both participants and treating doctors will not know which treatment participants received. When blood pressure goal is not reached after a moderate dose of drugs that raise blood pressure, an open-label steroid treatment will be given to participants as indicated in the current guidelines.
Eligibility
Inclusion Criteria3
- Age of 18 years or older
- Suspected or definite sepsis Sepsis is defined by SEPSIS-3 definition as Sequential Organ Failure Assessment (SOFA) score ≥ 2 from baseline with suspected infection.2 Suspected sepsis is defined as patients with suspected infection who meet 2 or more criteria of quick SOFA (altered mentation, respiratory rate ≥ 22/min, systolic blood pressure ≤ 100 mmHg).
- Hypotension (mean arterial pressure \< 65 mmHg)
Exclusion Criteria11
- Randomization and administration of the study drugs are not able to be executed within 3 hours after the onset of hypotension
- Causes of shock other than sepsis identified
- Immunocompromised A patient is considered immunocompromised if one of the following criteria is met: history of human immunodeficiency virus infection or acquired immunodeficiency syndrome, hematologic malignancy, receiving chemotherapy, active cancer receiving chemotherapy, current use of immunosuppressive medication)
- Hyperglycemic crisis (diabetic ketoacidosis, hyperosmolar hyperglycemic state)
- Pregnancy
- Post-cardiac arrest
- Received etomidate before randomization
- Systemic corticosteroids indicated for other conditions
- Received systemic corticosteroids within 4 weeks at any dose
- Cancer patients who are receiving palliative treatment
- Do-not-resuscitate order
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Interventions
For the Early Hydrocortisone 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 intravenous infusion in 24 hours for 2 consecutive days (total 250 mg in day 1 and 200 mg in day 2). After completion of the study drugs for 2 days, the study drug will be discontinued without tapering.
For the Standard Care group, a bolus of 10 ml of normal saline will be given, then 100 ml of normal saline will be given as continuous intravenous infusion in 24 hours for 2 consecutive days as a sham control. After completion of the study drugs for 2 days, the study drug will be discontinued without tapering.
An open-label 50 mg of hydrocortisone given as an intravenous bolus followed by intravenous hydrocortisone 200 mg/day given as continuous infusion or divided bolus administration is suggested to be commenced in both study arms if the hemodynamic goal of the patient is not reached despite the dose of norepinephrine or epinephrine ≥ 0.25 mcg/kg/min at least 4 hours after the initiation of the vasopressors as recommended by the guideline. The study drug in each arm will be discontinued once an open-label hydrocortisone is initiated. Capillary or venous blood glucose will be tested at least every 6 hours for 2 days then at least once daily or more as appropriate for the first 7 days as a part of the study protocol.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06217939