Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMSS Hospital General de Zona 11, Piedras Negras
• Treatments: Ascorbic Acid; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydroquinone; Hydroxocobalamin; Pyridoxal; Pyridoxine; Thiamine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

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