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Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREATMENT with Vitamins C and B1 | Experimental | Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
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| PLACEBO with saline only | No Intervention | Patients in the placebo (control group) arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rates | All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days) | From time of treatment to 30 days post hospital discharge, up to 87 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Total number of days patient is admitted to the hospital | From admission to the hospital through hospital discharge, up to 57 days. |
| Intensive Care Unit Length of Stay |
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Patients must meet all inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Shapiro, MD | Saint Francis Hospital and Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
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The only exclusions for for patients who opted out of the study following initial consent. No other run-in events occurred.
Patients admitted to the intensive care unit with a diagnosis of septic shock were identified by study team members, offered for recruitment, recruited and randomized upon arrival to the unit. This began September 14, 2018 and the final recruitment occurred on February 22, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamins C and B1 | Patients in this arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). Vitamin C: Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). Vitamin B1: Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
| FG001 | Placebo | Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamins C and B1 | Patients in this arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). Vitamin C: Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). Vitamin B1: Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality Rates | All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days) | Posted | Count of Participants | Participants | From time of treatment to 30 days post hospital discharge, up to 87 days. |
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Adverse events were collected from the time of enrollment into the study, during hospital stay and continued until 30 days following discharge from the hospital, up to 87 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamins C and B1 | Patients in this arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). Vitamin C: Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). Vitamin B1: Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to sepsis or septic shock | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Shapiro, MD, MHCM, FACS, FCCM CMO of Saint Francis Hospital and Medical Center | Saint Francis Hospital and Medical Center | 860-833-5673 | dshapiro@trinityhealthofne.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2020 | Mar 8, 2022 | Prot_SAP_000.pdf |
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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 |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All parties involved, except for pharmacy personnel will be blinded.
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| Vitamin B1 | Drug | Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
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Total number of days patient is admitted to the ICU
| From time of admission to the ICU through discharge from the ICU, up to 25 days |
| Readmission Rate | Readmission to the hospital within 30 days after discharge | 30 days after hospital discharge |
| Ventilator Days | Number of days patient required ventilator | From admission to the ICU through discharge from the ICU, up to 25 days. |
| Hours on Vasopressors | Number of hours patient required vasopressors in norepinephrine equivalence. | From admission to the ICU through discharge from the ICU, up to 25 days. |
| BG001 | Placebo | Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| OG001 | Placebo | Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
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| Secondary | Hospital Length of Stay | Total number of days patient is admitted to the hospital | Posted | Median | Inter-Quartile Range | days | From admission to the hospital through hospital discharge, up to 57 days. |
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| Secondary | Intensive Care Unit Length of Stay | Total number of days patient is admitted to the ICU | Posted | Median | Inter-Quartile Range | days | From time of admission to the ICU through discharge from the ICU, up to 25 days |
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| Secondary | Readmission Rate | Readmission to the hospital within 30 days after discharge | 54 patients received treatment, 11 died during initial admission and therefore excluded from readmission statistics. Of the 52 patients in the control group 7 died during initial admission and were excluded from readmission statistics. One control patient was withdrawn and also could not be considered for readmission statistics. | Posted | Number | participants | 30 days after hospital discharge |
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| Secondary | Ventilator Days | Number of days patient required ventilator | Intervention arm-1 patient made CMO and terminally extubated, 1 patient had insufficient data. Control-3 patients made CMO then terminally extubated | Posted | Mean | Standard Deviation | days on ventilator | From admission to the ICU through discharge from the ICU, up to 25 days. |
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| Secondary | Hours on Vasopressors | Number of hours patient required vasopressors in norepinephrine equivalence. | Posted | Mean | Standard Deviation | Hours | From admission to the ICU through discharge from the ICU, up to 25 days. |
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| 12 |
| 54 |
| 17 |
| 54 |
| 0 |
| 54 |
| EG001 | Placebo | Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. | 7 | 52 | 15 | 52 | 0 | 52 |
| Readmissions within 30 days | Infections and infestations | Systematic Assessment | Readmissions within 30 days of index hospitalization |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |