Severe SepsisPhase 2NCT01590303
Outcome Following Vitamin C Administration in Sepsis
A Phase 2 study testing Vitamin C in people with Severe Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of severe sepsis
- admitted to the intensive care unit
Who cannot join
- allergy to Vitamin C
- history of kidney stones
- glucose-6-phosphate dehydrogenase deficiency
- history of iron overload/hemochromatosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
Michael Sharpe, MD FRCPC, michael.sharpe@lhsc.on.ca
Tracey Bentall, RN, 5196858500, tracey.bentall@lhsc.on.ca
About this study
Official title: A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.
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.
Read the 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
- Being tested
- Vitamin C, placebo
- Keywords
- severe sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
placeboDrug
placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit Receives: Drug: Vitamin C |
| placebo | Placebo comparator | placebo vehicle administered in same fashion as active treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days or discharge from intensive care unit
Secondary outcomes (1)
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-1α
Measured: 28 days or discharge from intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sharpe, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael D Sharpe, MD FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590303
- Sponsor's protocol ID
- UWO HSREB #18803
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.
- ClinicalTrials.gov ID
- NCT01590303
- Acronym / sponsor ID
- UWO HSREB #18803
- Conditions
- Severe Sepsis
- Keywords
- severe sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin CIntravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit |
| placebo | Placebo comparator | Drug: placeboplacebo vehicle administered in same fashion as active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of severe sepsis
- admitted to the intensive care unit
Key exclusion criteria (4 listed)
- allergy to Vitamin C
- history of kidney stones
- glucose-6-phosphate dehydrogenase deficiency
- history of iron overload/hemochromatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CIntravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit | Drug | Vitamin C |
| placeboplacebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU | Drug | placebo |
Primary outcome
Sequential organ function assessment score (SOFA)
Time frame: 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.
1 secondary outcome
Biomarkers as a measure of coagulation, inflammation and oxidative stress.
Time frame: 28 days or discharge from intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Sharpe, MD FRCPC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Severe Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracey Bentall, RN (5196858500 ext. 32546, tracey.bentall@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequential organ function assessment score (SOFA) (time frame: 28 days or discharge from intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.