Outcome Following Vitamin C Administration in Sepsis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.|
- Sequential organ function assessment score (SOFA) [ Time Frame: 28 days or discharge from intensive care unit ] [ Designated as safety issue: Yes ]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.
- Biomarkers as a measure of coagulation, inflammation and oxidative stress. [ Time Frame: 28 days or discharge from intensive care unit ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Vitamin C
Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit
Drug: Vitamin C
Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
Placebo Comparator: placebo
placebo vehicle administered in same fashion as active treatment
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU
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.
|Contact: Tracey Bentall, RN||5196858500 ext email@example.com|
|Contact: Michael D Sharpe, MD FRCPCfirstname.lastname@example.org|
|London Health Sciences Centre - University Hospital||Not yet recruiting|
|London, Ontario, Canada, N6A5A5|
|Contact: Michael Sharpe, MD FRCPC email@example.com|
|Contact: Tracey Bentall, RN 5196858500 firstname.lastname@example.org|
|Sub-Investigator: Norman Smith, MSc, PhD|
|Sub-Investigator: Claudio Martin, MD FRCPC|
|Sub-Investigator: Tina Mele, MD FRCPC|
|Principal Investigator:||Michael D Sharpe, MD FRCPC||London Health Sciences Centre|