Outcome Following Vitamin C Administration in Sepsis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: Vitamin C
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of severe sepsis admitted to the intensive care unit Exclusion Criteria: allergy to Vitamin C history of kidney stones glucose-6-phosphate dehydrogenase deficiency history of iron overload/hemochromatosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C<br>Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit | Drug: Vitamin C<br>* Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit<br>|
| Placebo Comparator: placebo<br>placebo vehicle administered in same fashion as active treatment | Drug: placebo<br>* placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe sepsis