Severe Sepsis
Conditions
Keywords
severe sepsis
Brief summary
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
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.
Interventions
DRUGVitamin C
Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
DRUGplacebo
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sequential organ function assessment score (SOFA) | 28 days or discharge from intensive care unit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers as a measure of coagulation, inflammation and oxidative stress. | 28 days or discharge from intensive care unit | 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 |
Countries
Canada
Contacts
Primary ContactTracey Bentall, RN
Backup ContactMichael D Sharpe, MD FRCPC
Outcome results
None listed