Burns Clinical Trial
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
NCT number | NCT05612867 |
Other study ID # | 20-49 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 12, 2020 |
Est. completion date | January 8, 2021 |
Verified date | October 2022 |
Source | Arrowhead Regional Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | January 8, 2021 |
Est. primary completion date | January 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: All patients presenting to Arrowhead Regional Medical Center Emergency Department with International Classification of Diseases-10 codes of : i. 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 Exclusion Criteria: - Total Body Surface Area Burns under 20%. |
Country | Name | City | State |
---|---|---|---|
United States | Arrowhead Regional Medical Center | Colton | California |
Lead Sponsor | Collaborator |
---|---|
Arrowhead Regional Medical Center |
United States,
Barbosa E, Faintuch J, Machado Moreira EA, Gonçalves 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. — View Citation
Kessler 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. — View Citation
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. — View Citation
May JM. How does ascorbic acid prevent endothelial dysfunction? Free Radic Biol Med. 2000 May 1;28(9):1421-9. Review. — View Citation
Rock 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. — View Citation
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. — View Citation
Wang 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Survival within the first 28 days | 28 hours | |
Primary | Infection rate | The time frame of any clinically documented infections and when they occurred | 180 days | |
Primary | 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 | 180 days | |
Primary | Fluid Requirement | Total fluid requirements in first 72 hours | 72 hours |
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