Outcome Following Vitamin C Administration in Sepsis

Phase 2

• Conditions: Severe Sepsis
• Interventions: Drug: placebo; Drug: Vitamin C

• Registration Number: NCT01590303
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-05
• Study Start: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Last Update Submitted: 2012-05-01
• Study First Posted: 2012-05-02
• Last Update Posted: 2012-05-02
• Primary Completion: 2013-06
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo vehicle administered in same fashion as active treatment
Vitamin C	Vitamin C	Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit

Primary Outcome Measures

Name	Time	Method
Sequential organ function assessment score (SOFA)	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

Name	Time	Method
Biomarkers as a measure of coagulation, inflammation and oxidative stress.	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

Trial Locations

Locations (1)

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada