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This study is designed to determine if Vitamin C administration to septic patients will result in an improvement in organ dysfunction which occurs during a septic illness.
Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce the length of time on a ventilator, length of stay in the intensive care unit and in hospital.
This study will measure biomarkers of inflammation, coagulation and oxidative stress. These biomarkers have been shown to be increased during periods of oxidative stress eg post-operative, trauma, sepsis. The investigators will determine if Vitamin C administration decreases oxidative stress and as a result, a decrease in the markers of organ dysfunction eg SOFA Scores. Ultimately, if the investigators show a decrease in injury to organs, will this result in a better outcome for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit |
|
| placebo | Placebo Comparator | placebo vehicle administered in same fashion as active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sequential organ function assessment score (SOFA) | Scoring system to determine the extent of a patient's organ function or rate of failure. The score based on 6 different scores; one each for respiratory, hepatic, cardiovascular, renal, coagulation, neurologic. | 28 days or discharge from intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers as a measure of coagulation, inflammation and oxidative stress. | Vitamin C Assays - Plasma/WBC Cytokines (8- plex) Adhesion Molecules Procalcitonin C-Reactive Protein,H igh Sensitivity High Density Lipoprotein Cholesterol Tbars F2 isoprostane Neutrophil elastase Thrombomodulin Free DNA HIF-1α | 28 days or discharge from intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracey Bentall, RN | Contact | 5196858500 | 32546 | tracey.bentall@lhsc.on.ca |
| Michael D Sharpe, MD FRCPC | Contact | 5196633030 | michael.sharpe@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael D Sharpe, MD FRCPC | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre - University Hospital | London | Ontario | N6A5A5 | Canada |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| placebo | Drug | placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |