Septic Shock Clinical Trial
Official title:
Steroids, Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS): A Prospective Crossover Randomized Controlled Study
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).
This trial is designed as a multi-center prospective, double-blinded, randomized controlled
study. The objective of this project is to determine if in patients admitted to the hospital
with septic shock (population), does treatment with a bundle including hydrocortisone,
thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or
surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2)
duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4)
incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes). The
calculated sample size is 80. Subjects will be followed for 28 days or until hospital
discharge.
Patients eligible for inclusion must be admitted with septic shock (as defined by SEPSIS-3)
requiring vasopressors to maintain MAP ≥ 65 AND serum lactate level >2 mmol/L after adequate
fluid resuscitation (generally recognized at 30 ml/kg crystalloid unless contraindicated as
deemed by treating clinician) within the first three hours.
The exclusion criteria are: age < 18 years, pregnant, patients with limitation of care (i.e.
do not resuscitate [DNR]), known Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, and
vasopressor use for > 24 hours prior to study enrollment.
Patients in Arm 1 will randomized to receive usual care + hydrocortisone, thiamine and
ascorbic acid. Arm 2 will be randomized to receive usual care alone. Crossover is not
allowed. If a patient is randomized into study Arm 2, the treating physician may decide to
administer study medications if they feel it is in the best interest of the patient. In this
case the patient will continue to be analyzed in their assigned arm on an intention to treat
basis. Source of participants will be in-hospital and Emergency Department patients.
;
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