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

NCT04197115 | Completed Phase 3

• 1 other identifier: F-2019-506-010
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; Vitamin C; Hydrocortisone; Mortality

Outcome Measures

Primary Outcomes (2)

• Difference in hospital mortality in phase 1 vs phase 2 groups

  Quantitative variable: Metric unit: number (percentage); Mortality in hospital

  1 year

• Difference in Intensive Care Unit Mortality in phase 1 vs phase 2 groups

  Quantitative variable; Metric unit: number (percentage); Mortality in Intensive Care Unit

  1 year

Secondary Outcomes (2)

• Difference in SOFA (Sequential Organ Failure Assessment) between phase 1 vs phase 2 groups

  1 year

• Difference in number of days with vasopressor use between phase 1 vs phase 2 groups.

  1 year

Study Arms (2)

Phase 1

NO INTERVENTION

Septic patients admited to ICU whick will be treated as specified in current guidelines.

Phase 2

ACTIVE COMPARATOR

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)

Drug: Vitamin C; Drug: Hydrocortisone; Drug: Complex B

Interventions

Vitamin C DRUG

Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

Also known as: ascorbic acid

Phase 2

Hydrocortisone DRUG

Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.

Also known as: Hydrocortisone sodium succinate

Phase 2

Complex B DRUG

Complex B ((Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) 1 tablet enteral route every 6 horas for 4 days or until ICU discharge

Also known as: vitamin B complex

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Anticipated or confirmed intensive care unit (ICU) admission

You may not qualify if:

• Organ dysfunction present \> 24 hours at time of enrollment
• 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

Sponsors & Collaborators

• IMSS Hospital General de Zona 11, Piedras Negras: lead

Study Sites (1)

Hospital General Zona 11 Imss Piedras Negras Coahuila

Piedras Negras, Coahuila, 26020, Mexico

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ascorbic Acid; Hydrocortisone; Hydroquinones; Vitamin B Complex

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD

  IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit Jose Ivan RodriguezdeMolina Critical Care Ph.

Model Details: Prospective longitunal experimental

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: September 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)