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

October 15, 2020 updated by: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, IMSS Hospital General de Zona 11, Piedras Negras

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.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Coahuila
      • Piedras Negras, Coahuila, Mexico, 26020
        • Hospital General Zona 11 Imss Piedras Negras Coahuila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Phase 1
Septic patients admited to ICU whick will be treated as specified in current guidelines.
Active Comparator: 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)

Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
Other Names:
  • ascorbic acid
Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Names:
  • Hydrocortisone sodium succinate
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
Other Names:
  • vitamin B complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in hospital mortality in phase 1 vs phase 2 groups
Time Frame: 1 year
Quantitative variable: Metric unit: number (percentage); Mortality in hospital
1 year
Difference in Intensive Care Unit Mortality in phase 1 vs phase 2 groups
Time Frame: 1 year
Quantitative variable; Metric unit: number (percentage); Mortality in Intensive Care Unit
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in SOFA (Sequential Organ Failure Assessment) between phase 1 vs phase 2 groups
Time Frame: 1 year
Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points.
1 year
Difference in number of days with vasopressor use between phase 1 vs phase 2 groups.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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