Outcome Following Vitamin C Administration in Sepsis

Lawson Health Research Institute

Status and phase: Unknown; Phase 2

Conditions: Severe Sepsis

Treatments: Drug: Vitamin C; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01590303

UWO HSREB #18803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Vitamin C

Experimental group

Description:

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

Treatment:

Drug: Vitamin C

placebo

Placebo Comparator group

Description:

placebo vehicle administered in same fashion as active treatment

Treatment:

Drug: placebo