Clinical trial NCT04197115: Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis
Official title: Difference in Mortality and Evolution in Septic Patients Treated With Vitamin C, Tiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone Treated at the ICU of General Hospital Zone 11 IMSS Piedras Negras Coahuila.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Septic Shock
Keywords: sepsis
septic shock
Vitamin C
Hydrocortisone
Mortality
Lead sponsor: IMSS Hospital General de Zona 11, Piedras Negras
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective longitunal experimental
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Difference in hospital mortality in phase 1 vs phase 2 groups
timeFrame: 1 year
measure: Difference in Intensive Care Unit Mortality in phase 1 vs phase 2 groups
timeFrame: 1 year
Secondary outcomes:
measure: Difference in SOFA (Sequential Organ Failure Assessment) between phase 1 vs phase 2 groups
timeFrame: 1 year
measure: Difference in number of days with vasopressor use between phase 1 vs phase 2 groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Piedras Negras
country: Mexico
facility: Hospital General Zona 11 Imss Piedras Negras Coahuila
state: Coahuila
Study officials:
affiliation: IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO
name: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD
role: PRINCIPAL_INVESTIGATOR
References: