Outcome Following Vitamin C Administration in Sepsis

Severe Sepsis Clinical Trial

Official title:

A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01590303
• Other study ID #: UWO HSREB #18803
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 1, 2012
• Last updated: May 1, 2012
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2012
• Source: Lawson Health Research Institute
• Contact: Tracey Bentall, RN
• Phone: 5196858500
• Email: tracey.bentall[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

Drug:
• Vitamin C
Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
• placebo
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days or discharge from intensive care unit	Yes
Secondary	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-1a	28 days or discharge from intensive care unit	No