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Outcome Following Vitamin C Administration in Sepsis

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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
Sponsor:
Information provided by (Responsible Party):
Michael Sharpe, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Vitamin C Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin C
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: placebo
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Tracey Bentall, RN 5196858500 ext 32546 tracey.bentall@lhsc.on.ca
Contact: Michael D Sharpe, MD FRCPC 5196633030 michael.sharpe@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre - University Hospital Not yet recruiting
London, Ontario, Canada, N6A5A5
Contact: Michael Sharpe, MD FRCPC       michael.sharpe@lhsc.on.ca   
Contact: Tracey Bentall, RN    5196858500    tracey.bentall@lhsc.on.ca   
Sub-Investigator: Norman Smith, MSc, PhD         
Sub-Investigator: Claudio Martin, MD FRCPC         
Sub-Investigator: Tina Mele, MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre

Responsible Party: Michael Sharpe, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01590303     History of Changes
Other Study ID Numbers: UWO HSREB #18803
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by Michael Sharpe, Lawson Health Research Institute:
severe sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents