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

NCT ID: NCT04197115

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-09-30

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.

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Phase 2

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)

Group Type: ACTIVE_COMPARATOR

Vitamin C

Intervention Type: DRUG

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

Hydrocortisone

Intervention Type: DRUG

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

Complex B

Intervention Type: 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

Interventions

Vitamin C

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

Intervention Type: DRUG

Hydrocortisone

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

Intervention Type: DRUG

Complex B

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

Intervention Type: DRUG

Other Intervention Names

ascorbic acid; Hydrocortisone sodium succinate; vitamin B complex

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

• 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

Exclusion Criteria

• Organ dysfunction present > 24 hours at time of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IMSS Hospital General de Zona 11, Piedras Negras

OTHER

Sponsor Role: lead

Responsible Party

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO

Head of Intensive Care Unit Jose Ivan RodriguezdeMolina Critical Care Ph.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD

Role: PRINCIPAL_INVESTIGATOR

IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO

Locations

Hospital General Zona 11 Imss Piedras Negras Coahuila

Piedras Negras, Coahuila, Mexico

Countries

Mexico

Other Identifiers

F-2019-506-010

Identifier Type: -

Identifier Source: org_study_id