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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Difference in number of days with vasopressor use between phase 1 vs phase 2 groups. |
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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
Anticipated or confirmed intensive care unit (ICU) admission
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD | IMSS HGZ 11 UTI PIEDRAS NEGRAS COAHUILA MEXICO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Zona 11 Imss Piedras Negras Coahuila | Piedras Negras | Coahuila | 26020 | Mexico |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D006854 | Hydrocortisone |
| D006873 | Hydroquinones |
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Prospective longitunal experimental
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| Hydrocortisone | Drug | Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. |
|
|
| 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 |
|
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |