Outcome Following Vitamin C Administration in Sepsis

NCT01590303 | Unknown Phase 2

• 1 other identifier: UWO HSREB #18803
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis

Keywords

severe sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Biomarkers as a measure of coagulation, inflammation and oxidative stress.

  28 days or discharge from intensive care unit

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Drug: Vitamin C

placebo

PLACEBO COMPARATOR

placebo vehicle administered in same fashion as active treatment

Drug: placebo

Interventions

Vitamin C DRUG

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

Vitamin C

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of severe sepsis
• admitted to the intensive care unit

You may not qualify if:

• allergy to Vitamin C
• history of kidney stones
• glucose-6-phosphate dehydrogenase deficiency
• history of iron overload/hemochromatosis

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Sepsis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Michael D Sharpe, MD FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracey Bentall, RN

CONTACT

5196858500; tracey.bentall@lhsc.on.ca

Michael D Sharpe, MD FRCPC

CONTACT

5196633030; michael.sharpe@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 2, 2012

Record last verified: 2012-05

Locations

CA (1)