vitamin c, thiamine, cyanocobalamine, pyridoxine and hydrocortisone in sepsis

Conditions: Sepsis; Septic Shock

Summary: prospective, experimental, longitudinal cohort study in septic patients treated at er and icu at general hospital zone 11 imss piedras negras coahuila. interventions, will be implementd in 2 consecutive periods of 6 months phase 1: 6 months period, septic patients treated only with standard treatment. phase 2: 6 months period, septic patients treated with vitamin c, thiamine, cyanocobalamine, pyridoxine and hydrocortisone + standard treatment.

the research protocol will consist of two phases: phase 1: collection of statistical data of septic patients in whom standard treatment will be applied according to clinical practice guidelines, with an approximate duration of 6 months phase 2: experimental period lasting 6 months in which the standard treatment will be applied according to clinical practice guidelines + the treatment protocol consisting of vitamin c 1.5 g iv every 6 hours, hydrocortisone 50 mg iv every 6 hours and in case of having enteral route complex b (thiamine 100 mg, pyridoxine 5 mg, cyanocobalamin 50 mcg) 1 tablet every 6 hours for 4 continuous days or until discharge from the icu patient.

Eligibility criteria:
inclusion criteria: * suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent * acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements: * vasopressor requirement - continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm hg despite intravenous crystalloid infusion of at least 1000cc * respiratory support requirement - acute hypoxemic respiratory failure defined as persistent hypoxemia ( partial pressure of arterial oxygen (pao2)/fraction of inspired oxygen (fio2) ≤ 300 or blood oxygen saturation (spo2)/fio2 ≤ 315) requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight- fitting f ace mask (i.e. continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) or (3) high flow nasal cannula ≥ 45 liter per minute (lpm) flow and fio2 * 0.40 * anticipated or confirmed intensive care unit (icu) admission exclusion criteria: * organ dysfunction present \> 24 hours at time of enrollment * limitations of care (defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria 7.1.b) including "do not intubate" (dni) status * current hospitalization \> 30 days at time of randomization * chronic hypoxemia requiring supplemental non-invasive oxygen (nasal cannula or nippv) or home mechanical ventilation * chronic cardiovascular failure requiring home mechanical hemodynamic support (e.g., lvad) or home chemical hemodynamic support (e.g., milrinone) * known allergy or contraindication to vitamin c, thiamine, and/or corticosteroids (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or nown/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (g6pd) deficiency) * currently receiving intravenous vitamin c as a treatment for sepsis or any dose of vitamin c exceeding 1 gram daily * chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of \< 30 days unrelated to current sepsis diagnosis (e.g., stage iv malignancy, neurodegenerative disease, etc.) * pregnancy or known active breastfeeding * prisoner or incarceration * current participation in another interventional pharmaceutical research study for sepsis inability or unwillingness of subject or legal surrogate/representative to give written informed consent

Keywords: sepsis septic shock vitamin c hydrocortisone mortality