Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock. (HSHC00582434)

Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.

Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock.

We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.

Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.

Patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days.

Patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.

In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.

The primary end point was to determine a difference in 28-day mortality between the 200-mg and 300-mg groups.

Permanent shock (PS) was defined as permanent catecholamine support (epinephrine or norepinephrine) in the ICU, from the onset of septic shock to death without a period of reversal.

Post hydrocortisone hemodynamic rebound (PHHR) was defined as SR within 48 hours after hydrocortisone cessation.

Incidences of hemorrhagic events, superinfections and the amount of needed insulin were compared between the two groups.

Inclusion Criteria: patients over 18 years old septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines. no minimal vasopressor dose was needed to enter the trial. Exclusion Criteria: medical history of adrenal insufficiency ongoing corticosteroid treatment pregnancy