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Outcome Following Vitamin C Administration in Sepsis

This study is not yet open for participant recruitment.
Verified May 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Michael Sharpe, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01590303
First received: May 1, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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 Intervention Phase
Severe Sepsis
 Drug: Vitamin C
Drug: placebo
 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:

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

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michael Sharpe, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01590303     History of Changes
Other Study ID Numbers: UWO HSREB #18803
Study First Received: May 1, 2012
Last Updated: May 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
severe sepsis

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

ClinicalTrials.gov processed this record on May 19, 2013