BurnsNCT05612867
Low Dose Vitamin C in Burns >20% Compared to Previous Studies With High Dose Vitamin C
An observational study of Burns and Ascorbic Acid Deficiency, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns, Ascorbic Acid Deficiency, Burn Shock
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2020to 8 Jan 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: To evaluate PO vitamin C in burns of greater than 20% total body surface area compared to previous published studies utilizing high dose vitamin C in patients older than 18 years of age.
Who may be able to join
- All patients presenting to Arrowhead Regional Medical Center Emergency Department with International Classification of Diseases-10 codes of :
- T31.2 Burns involving 20-29% of body surface ii. T31.3 Burns involving 30-39% of body surface iii. T31.4 Burns involving 40-49% of body surface iv. T31.5 Burns involving 50-59% of body surface v. T31.6 Burns involving 60-69% of body surface vi. T31.7 Burns involving 70-79% of body surface vii. T31.8 Burns involving 80-89% of body surface viii. T31.9 Burns involving 90% or more of body surface ix. T30.2 Burn of second degree, body region unspecified x. T30.3 Burn of third degree, body region unspecified
Who cannot join
- Total Body Surface Area Burns under 20%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: High Dose Intravenous Versus Low Dose Oral Vitamin C in Burn Care: Potential Protective Effects in the Severely Burned: A Retrospective Cohort Study
Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the Systemic Inflammatory Response Syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue. Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. We aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on clinical outcomes such as length of hospital stay, total fluid requirements, and mortality.
Read the detailed description
Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the systemic inflammatory response syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue.
Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. While vitamin C is a regular part of burn resuscitation, there is no consensus on the most effective dose when considering impacting mortality, fluid resuscitation requirement, and other various clinical outcomes. Defining clinically efficacious minimal dosage of vitamin C can assist surgeons to better guide care for patients requiring burn resuscitation.
In this study, we aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on various clinical outcomes through a retrospective chart review of burn patients. Through this retrospective chart review, we aim to arrive at a better-defined vitamin C dose to achieve positive clinically significant outcomes.
- Conditions
- Burns, Ascorbic Acid Deficiency, Burn Shock, Burn Degree Second, Burn Degree Third, Fluid and Electrolyte Imbalance
- Being tested
- Vitamin C
- Medical subject headings
- Burns, Ascorbic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Due to clinical research supporting high dose vitamin C, the institution's surgical intensivists started utilizing a high IV vitamin C dose in higher total body surface area burns while continuing to use the standard PO vitamin C dose of 500 mg to 1,000 mg daily on patients with lower total body surface area burns. Looking at the initial 72 hours, patients with smaller burns were given 2,500 mg PO vitamin C and larger total body surface area burns were given 15,000 mg IV vitamin C.
| Study group | Role | What they receive |
|---|---|---|
| PO Vitamin C | Patients who got PO vitamin C Receives: Dietary Supplement: Vitamin C | |
| IV Vitamin C | Patients who got IV vitamin C Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Survival within the first 28 days
Measured: 28 hours
Infection rate
The time frame of any clinically documented infections and when they occurred
Measured: 180 days
Ventilator days
The total duration of time a patient spends intubated on a ventilator while in the hospital. The initial intubation will be the only intubation considered
Measured: 180 days
Fluid Requirement
Total fluid requirements in first 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start12 Dec 2020
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldin Malkoc, MD, Study chair, Arrowhead Regional Medical CenterDavid T Wong, MD, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612867
- Sponsor's protocol ID
- 20-49
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka H, Matsuda H, Shimazaki S, Hanumadass M, Matsuda T. Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. Arch Surg. 1997 Feb;132(2):158-61. doi: 10.1001/archsurg.1997.01430260056011.
PubMed 9041919Rock CL, Dechert RE, Khilnani R, Parker RS, Rodriguez JL. Carotenoids and antioxidant vitamins in patients after burn injury. J Burn Care Rehabil. 1997 May-Jun;18(3):269-78; discussion 268. doi: 10.1097/00004630-199705000-00018.
PubMed 9169953May JM. How does ascorbic acid prevent endothelial dysfunction? Free Radic Biol Med. 2000 May 1;28(9):1421-9. doi: 10.1016/s0891-5849(00)00269-0.
PubMed 10924860Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
PubMed 7492257Barbosa E, Faintuch J, Machado Moreira EA, Goncalves da Silva VR, Lopes Pereima MJ, Martins Fagundes RL, Filho DW. Supplementation of vitamin E, vitamin C, and zinc attenuates oxidative stress in burned children: a randomized, double-blind, placebo-controlled pilot study. J Burn Care Res. 2009 Sep-Oct;30(5):859-66. doi: 10.1097/BCR.0b013e3181b487a8.
PubMed 19692922Wang Y, Lin H, Lin BW, Lin JD. Effects of different ascorbic acid doses on the mortality of critically ill patients: a meta-analysis. Ann Intensive Care. 2019 May 20;9(1):58. doi: 10.1186/s13613-019-0532-9.
PubMed 31111241Matsuda 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 8300697
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Intravenous Versus Low Dose Oral Vitamin C in Burn Care: Potential Protective Effects in the Severely Burned: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05612867
- Acronym / sponsor ID
- 20-49
- Conditions
- Burns, Ascorbic Acid Deficiency, Burn Shock, Burn Degree Second, Burn Degree Third, Fluid and Electrolyte Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 10 Nov 2022 (actual)
- 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.
Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the Systemic Inflammatory Response Syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue. Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. We aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on clinical outcomes such as length of hospital stay, total fluid requirements, and mortality.
Detailed description
Burn injury is marked by a large release of inflammatory mediators which disrupt the normal capillary barrier and cause a rapid shift of intravascular fluid into interstitial spaces, ultimately leading to shock and death. As such, adequate fluid management and resuscitation is critical for burn patients to prevent further cellular injury. Technologies and medical options such as cardiac output monitoring along with early tube feeding and vitamin C administration have developed slowly over the years. Effective management of the systemic inflammatory response syndrome response and metabolic derangement is crucial for the survival of burn patients. In particular, vitamin C administration has shown to significantly decreases early post-burn lipid peroxidation, reduce microvascular leak of fluid by preventing endothelial dysfunction, and decreases edema formation in burned tissue.
Vitamin C is a cheap and widely available antioxidant which has been shown to significantly effective in positively impacting clinical outcomes in burn resuscitation. While vitamin C is a regular part of burn resuscitation, there is no consensus on the most effective dose when considering impacting mortality, fluid resuscitation requirement, and other various clinical outcomes. Defining clinically efficacious minimal dosage of vitamin C can assist surgeons to better guide care for patients requiring burn resuscitation.
In this study, we aim to evaluate the efficacy of vitamin C in burns greater than 20% total body surface area on various clinical outcomes through a retrospective chart review of burn patients. Through this retrospective chart review, we aim to arrive at a better-defined vitamin C dose to achieve positive clinically significant outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PO Vitamin C | – | Dietary Supplement: Vitamin CPatients who got PO vitamin C |
| IV Vitamin C | – | Dietary Supplement: Vitamin CPatients who got IV vitamin C |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- To evaluate PO vitamin C in burns of greater than 20% total body surface area compared to previous published studies utilizing high dose vitamin C in patients older than 18 years of age.
Key inclusion criteria (2 listed)
- All patients presenting to Arrowhead Regional Medical Center Emergency Department with International Classification of Diseases-10 codes of :
- T31.2 Burns involving 20-29% of body surface ii. T31.3 Burns involving 30-39% of body surface iii. T31.4 Burns involving 40-49% of body surface iv. T31.5 Burns involving 50-59% of body surface v. T31.6 Burns involving 60-69% of body surface vi. T31.7 Burns involving 70-79% of body surface vii. T31.8 Burns involving 80-89% of body surface viii. T31.9 Burns involving 90% or more of body surface ix. T30.2 Burn of second degree, body region unspecified x. T30.3 Burn of third degree, body region unspecified
Key exclusion criteria (1 listed)
- Total Body Surface Area Burns under 20%.
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 CDue to clinical research supporting high dose vitamin C, the institution's surgical intensivists started utilizing a high IV vitamin C dose in higher total body surface area burns while continuing to use the standard PO vitamin C dose of 500 mg to 1,000 mg daily on patients with lower total body surface area burns. Looking at the initial 72 hours, patients with smaller burns were given 2,500 mg PO vitamin C and larger total body surface area burns were given 15,000 mg IV vitamin C. | Dietary supplement | IV Vitamin C, PO Vitamin C |
Primary outcome
Mortality
Time frame: 28 hours
Survival within the first 28 days
Infection rate
Time frame: 180 days
The time frame of any clinically documented infections and when they occurred
Ventilator days
Time frame: 180 days
The total duration of time a patient spends intubated on a ventilator while in the hospital. The initial intubation will be the only intubation considered
Fluid Requirement
Time frame: 72 hours
Total fluid requirements in first 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 9041919Tanaka H, Matsuda H, Shimazaki S, Hanumadass M, Matsuda T. Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. Arch Surg. 1997 Feb;132(2):158-61. doi: 10.1001/archsurg.1997.01430260056011.
- Background: PubMed 9169953Rock CL, Dechert RE, Khilnani R, Parker RS, Rodriguez JL. Carotenoids and antioxidant vitamins in patients after burn injury. J Burn Care Rehabil. 1997 May-Jun;18(3):269-78; discussion 268. doi: 10.1097/00004630-199705000-00018.
- Background: PubMed 10924860May JM. How does ascorbic acid prevent endothelial dysfunction? Free Radic Biol Med. 2000 May 1;28(9):1421-9. doi: 10.1016/s0891-5849(00)00269-0.
- Background: PubMed 7492257Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
- Background: PubMed 19692922Barbosa E, Faintuch J, Machado Moreira EA, Goncalves da Silva VR, Lopes Pereima MJ, Martins Fagundes RL, Filho DW. Supplementation of vitamin E, vitamin C, and zinc attenuates oxidative stress in burned children: a randomized, double-blind, placebo-controlled pilot study. J Burn Care Res. 2009 Sep-Oct;30(5):859-66. doi: 10.1097/BCR.0b013e3181b487a8.
- Background: PubMed 31111241Wang Y, Lin H, Lin BW, Lin JD. Effects of different ascorbic acid doses on the mortality of critically ill patients: a meta-analysis. Ann Intensive Care. 2019 May 20;9(1):58. doi: 10.1186/s13613-019-0532-9.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Aldin Malkoc, MD study chair
Arrowhead Regional Medical Center
David T Wong, MD principal investigator
Arrowhead Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Ascorbic Acid Deficiency, run by Arrowhead Regional Medical Center 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 1 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 28 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 NCT05612867, which also lists 7 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 10 Nov 2022.