Early Intravenous Hydrocortisone in Sepsis

NARecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Sepsis SevereShock, Septic
Interventions
DRUG

Early hydrocortisone

"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."

DRUG

Normal saline placebo

"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."

DRUG

Open-label hydrocortisone

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.

Trial Locations (1)

10700

RECRUITING

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkoknoi

All Listed Sponsors
lead

Siriraj Hospital

OTHER