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

Primary Purpose

Sepsis, Septic Shock

Status

Completed

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Vitamin C

Hydrocortisone

Complex B

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, septic shock, Vitamin C, Hydrocortisone, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital General Zona 11 Imss Piedras Negras Coahuila

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Phase 1

Phase 2

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Difference in hospital mortality in phase 1 vs phase 2 groups

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

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

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

Secondary Outcome Measures

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

Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points.

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

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.

Full Information

NCT ID

NCT04197115

First Posted

December 10, 2019

Last Updated

October 15, 2020

Sponsor

IMSS Hospital General de Zona 11, Piedras Negras

1. Study Identification

Unique Protocol Identification Number

NCT04197115

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IMSS Hospital General de Zona 11, Piedras Negras

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Septic Shock

Keywords

sepsis, septic shock, Vitamin C, Hydrocortisone, Mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Model Description

Prospective longitunal experimental

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1

Arm Type

No Intervention

Arm Description

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

Arm Title

Phase 2

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Other Intervention Name(s)

ascorbic acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Other Intervention Name(s)

Hydrocortisone sodium succinate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Complex B

Other Intervention Name(s)

vitamin B complex

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in hospital mortality in phase 1 vs phase 2 groups

Description

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

Time Frame

1 year

Title

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

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

Quantitative variable: Maximal score of SOFA (Sequential Organ Failure Assessment) will be recorded; Value range 0-24 points.

Time Frame

1 year

Title

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

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD

Organizational Affiliation

IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital General Zona 11 Imss Piedras Negras Coahuila

City

Piedras Negras

State/Province

Coahuila

ZIP/Postal Code

26020

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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