BurnsVitamin CNCT00350077
The Effect of High Dose Vitamin C in Burn Patients
A study testing Intravenous Vitamin C and Vitamin C in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Burns
- What is being tested?
- Intravenous Vitamin C and Vitamin C
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2008
- Phase
- Interventional
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 20% total body surface area full and partial thickness burns
- Admitted to the USAISR burn center within 10 hours post injury
Who cannot join
- Pregnant or breast feeding
- Documented preadmission or admission renal failure
- History of glucose-6-phosphate dehydrogenase deficiency, kidney stoves, gout or sickle cell
- Electrical injury
- Renal replacement of any kind<24 hours after admission
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation
The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours.
Read the detailed description
Adequate fluid resuscitation in burn injured patients to allow adequate renal blood flow has been the hallmark of burn care in the last 50 years. The danger of exceeding the optimal intravenous fluid resuscitation has resulted in severe complications including abdominal compartment syndrome, loss of upper airway control, extremity compartment syndromes and pulmonary edema. Hig dose vitamin C infusion during the first 24 hours of burn resuscitation has been documented to decrease the overall amount of intravenous fluid needed to provide for adequate renal perfusion and hemodynamic stability in multiple animal model studies. High dose vitamin C is thought to decrease postburn microvascular protein and fluid leakage by reducing postburn lipid oxygenation caused by burn injury generated free radicals.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Vitamin CDrug
vitamin C IV during 24 hour period following burn
Vitamin CDrug
IV vitamin C
What is being measured
The primary outcome is the main question the study is designed to answer.
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group
Measured: 72 hours
Document a significantly higher number of mechanical ventilator free days
Measured: 7 days
Document a significantly lower complication and infection rate in the Vitamin C group
Measured: 7 days
Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level
Measured: 72 hours
Secondary outcomes (1)
Document a lower incidence of organ failure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Inadequate resources to submit for approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Lorne H Blackbourne, MD, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350077
- Sponsor's protocol ID
- H-05-045
- Acronym
- Vitamin C
- Status last verified
- Dec 2011
- First submitted
- 6 Jul 2006
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuda T, Tanaka H, Yuasa H, Forrest R, Matsuda H, Hanumadass M, Reyes H. The effects of high-dose vitamin C therapy on postburn lipid peroxidation. J Burn Care Rehabil. 1993 Nov-Dec;14(6):624-9. doi: 10.1097/00004630-199311000-00007.
PubMed 8300697Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
PubMed 10722036
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Dose Versus Low Dose Intravenous Vitamin C (Ascorbic Acid)on Burn Injury Resuscitation
- ClinicalTrials.gov ID
- NCT00350077
- Acronym / sponsor ID
- Vitamin C / H-05-045
- Conditions
- Burns
- Keywords
- Burns
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate resources to submit for approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Collaborators
- University of Miami
- Study start
- Jul 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Jul 2006 (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.
The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours.
Detailed description
Adequate fluid resuscitation in burn injured patients to allow adequate renal blood flow has been the hallmark of burn care in the last 50 years. The danger of exceeding the optimal intravenous fluid resuscitation has resulted in severe complications including abdominal compartment syndrome, loss of upper airway control, extremity compartment syndromes and pulmonary edema. Hig dose vitamin C infusion during the first 24 hours of burn resuscitation has been documented to decrease the overall amount of intravenous fluid needed to provide for adequate renal perfusion and hemodynamic stability in multiple animal model studies. High dose vitamin C is thought to decrease postburn microvascular protein and fluid leakage by reducing postburn lipid oxygenation caused by burn injury generated free radicals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >/= 20% total body surface area full and partial thickness burns
- Admitted to the USAISR burn center within 10 hours post injury
Key exclusion criteria (5 listed)
- Pregnant or breast feeding
- Documented preadmission or admission renal failure
- History of glucose-6-phosphate dehydrogenase deficiency, kidney stoves, gout or sickle cell
- Electrical injury
- Renal replacement of any kind<24 hours after admission
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 |
|---|---|---|
| Intravenous Vitamin Cvitamin C IV during 24 hour period following burn | Drug | – |
| Vitamin CIV vitamin C | Drug | – |
Primary outcome
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group
Time frame: 72 hours
Document a significantly higher number of mechanical ventilator free days
Time frame: 7 days
Document a significantly lower complication and infection rate in the Vitamin C group
Time frame: 7 days
Document decreased lipid peroxidation by monitoring serum malondialdehyde (MDA) level
Time frame: 72 hours
1 secondary outcome
Document a lower incidence of organ failure
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Background: PubMed 8300697Matsuda T, Tanaka H, Yuasa H, Forrest R, Matsuda H, Hanumadass M, Reyes H. The effects of high-dose vitamin C therapy on postburn lipid peroxidation. J Burn Care Rehabil. 1993 Nov-Dec;14(6):624-9. doi: 10.1097/00004630-199311000-00007.
- Background: PubMed 10722036Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
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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.
Lorne H Blackbourne, MD principal investigator
United States Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Vitamin C and Vitamin C in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 20 Dec 2011. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document a significantly lower intravenous fluid requirement per percent total body surface area burn in the High Dose Vitamin C group (time frame: 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350077, which also lists 2 linked publications.
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 20 Dec 2011.