Low Dose Vitamin C in Burns >20% Compared to Previous Studies With High Dose Vitamin C

NCT05612867 — Completed, 54 participants, Arrowhead Regional Medical Center

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High Dose Intravenous Versus Low Dose Oral Vitamin C in Burn Care: Potential Protective Effects in the Severely Burned: A Retrospective Cohort Study

RegistryNCT05612867
StatusCompleted
Study typeObservational
Enrollment54 (Actual)
SponsorArrowhead Regional Medical Center (Other)
ConditionsBurns, Ascorbic Acid Deficiency, Burn Shock, Burn Degree Second, Burn Degree Third, Fluid and Electrolyte Imbalance
InterventionsVitamin C (Dietary supplement)
Datesstart 2020-12-12, primary completion 2021-01-08, completion 2021-01-08, first posted 2022-11-10, last updated 2022-11-10
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Burns All trials for Ascorbic Acid Deficiency All trials of Vitamin C

-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. 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PO Vitamin CDietary Supplement: Vitamin CPatients who got PO vitamin C
IV Vitamin CDietary Supplement: Vitamin CPatients who got IV vitamin C
  • Vitamin C (Dietary 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.

+Outcome measures

Primary outcomes

  • Mortality [28 hours]: Survival within the first 28 days
  • Infection rate [180 days]: The time frame of any clinically documented infections and when they occurred
  • Ventilator days [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 [72 hours]: Total fluid requirements in first 72 hours

+Eligibility

Sex: All

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%.

+Locations (1)

FacilityCityCountryStatus
Arrowhead Regional Medical CenterColton, CaliforniaUnited States

+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. PMID 9041919
  • 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. doi: 10.1097/00004630-199705000-00018. PMID 9169953
  • May 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. PMID 10924860
  • 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. doi: 10.1001/archpsyc.1995.03950240066012. PMID 7492257
  • Barbosa 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. PMID 19692922
  • 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. PMID 31111241
  • Results publication: 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. PMID 8300697

+Investigators