Outcome Following Vitamin C Administration in Sepsis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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