Outcome Following Vitamin C Administration in Sepsis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01590303|
Recruitment Status : Unknown
Verified May 2012 by Michael Sharpe, Lawson Health Research Institute.
Recruitment status was: Not yet recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Drug: Vitamin C Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||September 2013|
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
- Sequential organ function assessment score (SOFA) [ Time Frame: 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.
- Biomarkers as a measure of coagulation, inflammation and oxidative stress. [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590303
|Contact: Tracey Bentall, RN||5196858500 ext firstname.lastname@example.org|
|Contact: Michael D Sharpe, MD FRCPCemail@example.com|
|London Health Sciences Centre - University Hospital||Not yet recruiting|
|London, Ontario, Canada, N6A5A5|
|Contact: Michael Sharpe, MD FRCPC firstname.lastname@example.org|
|Contact: Tracey Bentall, RN 5196858500 email@example.com|
|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|