Outcome Following Vitamin C Administration in Sepsis

NCT ID: NCT01590303

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-09-30

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.

Conditions

Severe Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin C

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

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DRUG

Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit

placebo

placebo vehicle administered in same fashion as active treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU

Interventions

Vitamin C

Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit

Intervention Type: DRUG

placebo

placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Michael Sharpe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael D Sharpe, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Countries

Canada

Central Contacts

Tracey Bentall, RN

Role: CONTACT

tracey.bentall@lhsc.on.ca

5196858500 ext. 32546

Michael D Sharpe, MD FRCPC

Role: CONTACT

michael.sharpe@lhsc.on.ca

5196633030

Facility Contacts

Michael Sharpe, MD FRCPC

Role: primary

michael.sharpe@lhsc.on.ca

Tracey Bentall, RN

Role: backup

tracey.bentall@lhsc.on.ca

5196858500

Other Identifiers

UWO HSREB #18803

Identifier Type: -

Identifier Source: org_study_id