Outcome Following Vitamin C Administration in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2012 by Lawson Health Research Institute.
Recruitment status was Not yet recruiting

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

Drug Information available for: Ascorbic acid Sodium ascorbate Magnesium ascorbate

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 30, 2016

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