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Outcome Following Vitamin C Administration in Sepsis

Primary Purpose

Severe Sepsis

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vitamin C
placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring severe sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin C

placebo

Arm Description

Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit

placebo vehicle administered in same fashion as active treatment

Outcomes

Primary Outcome Measures

Sequential organ function assessment score (SOFA)
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.
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

Full Information

First Posted
May 1, 2012
Last Updated
May 1, 2012
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01590303
Brief Title
Outcome Following Vitamin C Administration in Sepsis
Official Title
A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
severe sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo vehicle administered in same fashion as active treatment
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU
Primary Outcome Measure Information:
Title
Sequential organ function assessment score (SOFA)
Description
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.
Time Frame
28 days or discharge from intensive care unit
Secondary Outcome Measure Information:
Title
Biomarkers as a measure of coagulation, inflammation and oxidative stress.
Description
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
Time Frame
28 days or discharge from intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracey Bentall, RN
Phone
5196858500
Ext
32546
Email
tracey.bentall@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael D Sharpe, MD FRCPC
Phone
5196633030
Email
michael.sharpe@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Sharpe, MD FRCPC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sharpe, MD FRCPC
Email
michael.sharpe@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Tracey Bentall, RN
Phone
5196858500
Email
tracey.bentall@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Norman Smith, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Claudio Martin, MD FRCPC
First Name & Middle Initial & Last Name & Degree
Tina Mele, MD FRCPC

12. IPD Sharing Statement

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Outcome Following Vitamin C Administration in Sepsis

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