SepsisPhase 3NCT04197115
Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis
A Phase 3 study testing Vitamin C, Hydrocortisone and Complex B in people with Sepsis and Septic Shock, run by IMSS Hospital General de Zona 11, Piedras Negras at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Vitamin C, Hydrocortisone and Complex B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2019to 30 Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Zona 11 Imss Piedras Negras Coahuila
Piedras Negras, Coahuila, 26020
About this study
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.
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.
Read the 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
- Being tested
- Vitamin C, Hydrocortisone, Complex B
- Keywords
- sepsis, septic shock, Vitamin C, Hydrocortisone, Mortality
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called ascorbic acid
Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
HydrocortisoneDrug
Also called Hydrocortisone sodium succinate
Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Complex BDrug
Also called vitamin B complex
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Vitamin C; Drug: Hydrocortisone; Drug: Complex B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in hospital mortality in phase 1 vs phase 2 groups
Quantitative variable: Metric unit: number (percentage); Mortality in hospital
Measured: 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
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Sep 2019
- Primary completion30 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective longitunal experimental
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMSS Hospital General de Zona 11, Piedras Negras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, IMSS Hospital General de Zona 11, Piedras Negras
- Investigators
- JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, Principal investigator, IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197115
- Sponsor's protocol ID
- F-2019-506-010
- Status last verified
- Oct 2020
- First submitted
- 10 Dec 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04197115
- Acronym / sponsor ID
- F-2019-506-010
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, Vitamin C, Hydrocortisone, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- IMSS Hospital General de Zona 11, Piedras NegrasUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective longitunal experimental
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | No intervention | –Septic patients admited to ICU whick will be treated as specified in current guidelines. |
| Phase 2 | Active comparator | Drug: Vitamin C, Drug: Hydrocortisone, Drug: Complex BSeptic 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: ascorbic acidIntravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge. | Drug | Phase 2 |
| HydrocortisoneAlso: Hydrocortisone sodium succinateIntravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. | Drug | Phase 2 |
| Complex BAlso: vitamin B complexComplex B ((Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) 1 tablet enteral route every 6 horas for 4 days or until ICU discharge | Drug | Phase 2 |
Primary outcome
Difference in hospital mortality in phase 1 vs phase 2 groups
Time frame: 1 year
Quantitative variable: Metric unit: number (percentage); Mortality in hospital
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
2 secondary outcomes
Difference in SOFA (Sequential Organ Failure Assessment) between phase 1 vs phase 2 groups
Time frame: 1 year
Difference in number of days with vasopressor use between phase 1 vs phase 2 groups.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD principal investigator
IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C, Hydrocortisone and Complex B in people with Sepsis and Septic Shock, run by IMSS Hospital General de Zona 11, Piedras Negras at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in hospital mortality in phase 1 vs phase 2 groups (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.