Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis
- Conditions
- SepsisSeptic Shock
- Interventions
- Registration Number
- NCT04197115
- Lead Sponsor
- IMSS Hospital General de Zona 11, Piedras Negras
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 2 Complex B Septic patients admitted to ICU which will be treated as specified in current guidelines adding: Vitamin C Hydrocortisone B complex (Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) Phase 2 Vitamin C Septic patients admitted to ICU which will be treated as specified in current guidelines adding: Vitamin C Hydrocortisone B complex (Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) Phase 2 Hydrocortisone Septic patients admitted to ICU which will be treated as specified in current guidelines adding: Vitamin C Hydrocortisone B complex (Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg)
- Primary Outcome Measures
Name Time Method Difference in Intensive Care Unit Mortality in phase 1 vs phase 2 groups 1 year Quantitative variable; Metric unit: number (percentage); Mortality in Intensive Care Unit
Difference in hospital mortality in phase 1 vs phase 2 groups 1 year Quantitative variable: Metric unit: number (percentage); Mortality in hospital
- Secondary Outcome Measures
Name Time Method Difference in number of days with vasopressor use between phase 1 vs phase 2 groups. 1 year Quantitative variable; Metric unit: number of days with vasopressors; Vasopressors defined as use of at leas one or in addition of epinephrine, norepinephrine, dobutamine, dopamine, vasopressin.
Difference in SOFA (Sequential Organ Failure Assessment) between phase 1 vs phase 2 groups 1 year Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points.
Trial Locations
- Locations (1)
Hospital General Zona 11 Imss Piedras Negras Coahuila
🇲🇽Piedras Negras, Coahuila, Mexico