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

Phase 4
Completed
Conditions
Septic Shock
Interventions
Registration Number
NCT02768740
Lead Sponsor
Association Niçoise de Réanimation Médicale
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
200 mg groupHydrocortisone hemisuccinatePatients 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.
300 mg groupHydrocortisone hemisuccinatePatients 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.
Primary Outcome Measures
NameTimeMethod
Mortality28-day

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

Secondary Outcome Measures
NameTimeMethod
Incidence of permanent shock between groups28-day

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.

Incidence of shock relapse between groups28-day

Shock relapse (SR) was defined as recurrence of septic shock requiring catecholamine resumption.

Incidence of adverse events between groups.28-day

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

Incidence of post hydrocortisone hemodynamic rebound between groups28-day

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

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